Acucise® Procedural Pack Starter Pack

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: ACUCISE® PROCEDURAL PACK STARTER PACK FDA UDI
Generic Name: Ureteral stent-placement set FDA UDI
Device Name: Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B1201, URO TAMPONADE BALLOON CATH B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B3302, STENT, C-FLEX, 7/10F X 28CM B3303, STENT, C-FLEX, 7/10F X 30CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX FDA UDI
Model / Reference: BK001 FDA UDI
Description: Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B1201, URO TAMPONADE BALLOON CATH B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B3302, STENT, C-FLEX, 7/10F X 28CM B3303, STENT, C-FLEX, 7/10F X 30CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915125947 FDA UDI
FDA Product Code: KNY FDA UDI
DXT FDA UDI
EZB FDA UDI
FED FDA UDI
EYB FDA UDI
FAD FDA UDI
GMDN Term: Ureteral stent-placement set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 FDA UDI
870.1650 FDA UDI
876.1500 FDA UDI
876.4620 FDA UDI
Commercial Distribution: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Acucise® Procedural Pack Starter Pack by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 01713ddf-323d-4bb1-8418-71c1813b41df 35 fields · synced Jun 1, 2026