Acucise® Endopyelotomy System

GUDID 10607915111660

Gastro-urological guidewire, single-use

Primary Device ID	10607915111660
NIH Device Record Key	c94f427d-4fe7-420f-b9d3-d4695844182d
Commercial Distribution Discontinuation	2018-10-28
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Acucise® Endopyelotomy System
Version Model Number	B1005
Company DUNS	187129135
Company Name	APPLIED MEDICAL RESOURCES CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00607915111663 [Primary]
GS1	10607915111660 [Package] Contains: 00607915111663 Package: [1 Units] Discontinued: 2018-10-28 Not in Commercial Distribution

KNY	Accessories, Catheter, G-U

Steralize Prior To Use	false
Device Is Sterile	true

10607915111677	General Purpose Ureteral Catheter
10607915111660	Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT

Mark Image Registration \| Serial	Company Trademark Application Date
ACUCISE 74266054 1810631 Live/Registered	Applied Medical Resources Corporation 1992-04-13