ACUCISE MANUFACTURED BY APPLIED MEDICAL RESOURCES CORP.

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ACUCISE

Request for Information Form	Contact Information
Company Name	APPLIED MEDICAL RESOURCES CORP.
Address	22872 AVENIDA EMPRESA
City, State, Zip	RANCHO SANTA MARGARITA, CA 92688
Country	US
FDA Owner/Operator Phone	949-713-8000
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	EZN
FDA Classification Name	DILATOR, CATHETER, URETERAL
FDA Device Classification Code	Standards
FDA Regulation Number	876.5470
FDA Common Generic Name	LOW PRESSURE TAMPONADE BALLOON CATHETER
FDA Proprietary Device Name	ACUCISE
FDA Owner / Operator Number	2027111
FDA Owner / Operator Name	APPLIED MEDICAL RESOURCES
FDA Establishment Registration Number	2027111
FDA Registered Establishment Name	APPLIED MEDICAL RESOURCES CORP.
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	06-13-94
FDA Listing Status Code	Active
Differentiation	Applied Access Sheath The Applied Access Sheath facilitates endourologic procedures by gently dilating the ureter and providing a continuous working channel. Gentle dilation • Tapered dilator gently traverses ureteral orifice • Replaces expensive balloon dilators • Unique locking mechanism ensures simultaneous advancement of the dilator and sheath for added security Less trauma • Protects the ureter during repeated instrument exchanges • SL-6 Hydrophilic Coating facilitates advancement Continual access • Reduces procedural time • Protects scopes and delicate instruments from costly repairs
Keywords	N/A
Description	Ureteral Dilator and Access Sheath Set for Utereroscopic and Endourologic Procedures
Brochure	N/A
Product Website	N/A

Competitors of APPLIED MEDICAL RESOURCES CORP.

Our records indicate that the following medical device companies may manufacture a similar device.

	Company Name / Address / Phone	Proprietary Device Name	Common Generic Device Name
1	AESCULAP, INC. 3773 CORPORATE PKWY. CENTER VALLEY, PA 18034 US 800-258-1946 / 610-984-9074	VARIOUS	VARIOUS
2	ALBER MEDIZINTECHNIK ST. BARBARA WEG 24 FRIDINGEN, 78567 GM 49-746-3-97889 / 703-541-0196	MULTIPLE, PRIVATE LABEL	VARIOUS TYPES OF DILATORS
3	ALLWIN MEDICAL DEVICES, INC. 3305 E. MIRALOMA AVENUE SUITE 180 ANAHEIM, CA 92806 US 714-572-1709 / 714-572-1709	URETERAL DILATOR	URETERAL DILATOR
4	AMECO MEDICAL INDUSTRIES INDUSTRIAL AREA B4-PLOT 119 EAST 10TH OF RAMADAN CITY, EG 20-15-383067 / 20-15-383067	AMECATH URETERAL DILATOR CATHETER	URETERAL DILATOR
5	ASTRA TECH AB AMINOGATAN 1 MOLNDAL, S-431 21 SW 44-207-304 5000 / 46-31-7763000	LOFRIC DILACATH, REF. NO. 891640 AND 891840	LOFRIC DILACATH, REF. NO. 891640 AND 891840
6	BOSTON SCIENTIFIC IRELAND, LTD. BALLYBRIT BUSINESS PARK GALWAY, EI 508-652-5594 / 508-652-5594	PASSPORT; CARSON ZERO TIP	DILATOR, CATHETER, URETERAL
7	C.R. BARD, INC. 1211 MARY MAGNAN BLVD. MADISON, GA 30650 US 908-277-8000 / 908-277-8513	X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER, UROFORCE	BARD WOVEN URETERAL FILIFORM, URETERAL DILATORS, DILATION CATH
8	C.R. BARD, INC. 289 BAY RD. QUEENSBURY, NY 12804 US 908-277-8000 / 908-277-8513	MULTIPLE	VARIOUS TYPES & SIZES OF URETERAL FILIFORMS & FOLLOWERS
9	C.R. BARD, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US 908-277-8000 / 908-277-8513	MULTIPLE	VARIOUS TYPES AND SIZES OF URETERAL FILIFORMS AND FOLLOWERS
10	COMBINED INSTRUMENTS (PVT.), LTD. 13-A MODEL TOWN, UGOKI SAILKOT, PK 04-32-510243 / 05-24-510243	DILATOR, CATHETER, URETERAL	SAME
11	COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. SPENCER, IN 47460 US 812-829-4891 / 812-829-4891	COOK(R) URETERAL DILATOR SET	URETERAL DILATOR SET
12	DYNAMIC SURGICAL (PVT) LTD WAZIRABAD RD UGOKI SIALKOT, PK 92-52-3510268 / 92-52-3510268	DILATOR CATHETER URETERAL	DILATOR CATHETER URETERAL
13	KARL HAMMACHER GMBH STEINENDORFERSTR. 27 SOLINGEN, D-42699 GM / 212-262-500	MULTIPLE	VARIOUS TYPES OF CATHETER DILATOR, URETERAL
14	KARL STORZ GMBH & CO. KG MITTELSTRASSE 8 TUTTLINGEN, 78532 GM 49-74-617080 / 800-421-0837 4201	KARL STORZ DILATOR	VARIOUS MODELS OF DILATORS
15	MTP MEDICAL TECHNICAL PROMOTION GMBH TAKE-OFF GEWERBE PARK 46 NEUHAUSEN OBECK, D-78579 GM 49-74-617080 / 310-348-4201	KARL STORZ DILATOR	DILATOR
16	ONSET MEDICAL CORPORATION 13900 ALTON PARKWAY, SUITE 120 IRVINE, CA 92618 US 949-716-1100 18 / 949-716-1100 18	PATHWAY ACCESS SHEATH CATHETER, PATHWAY II ACCESS SHEATH CATHETER	STERILE CATHETER FOR ACCESS DURING NEPHROSTOMY PROCEDURES
17	SURGICON (PVT) LTD. P.O. BOX 244 KHADIM ALI RD. SIALKOT, PUNJAB, PK 92-432-262530 31 / 92-432-262531 32	DILATOR CATHETER URETERAL	DILATOR CATHETER URETERAL
18	TINOPAL SURGICAL CORP. (PVT), LTD. UNIT #1, 55/57-B. SMALL INDUSTRIES ESTATE SIALKOT, PUNJAB, 51311 PK 92-52-3255454 / 92-52-3552298	DILATOR, CATHETER, URETERAL	DILATOR, CATHETER, URETERAL