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Acucise® Endopyelotomy System

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
Acucise® Endopyelotomy System FDA UDI
Generic Name
Gastro-urological guidewire, single-use FDA UDI
Device Name
Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIRE FDA UDI
Model / Reference
B1005 FDA UDI
Description
Kit Includes: B1201, URO TAMPONADE BALLOON CATH H-110, HANDLE 10CC LF SEAL-005, SURESEAL II, INT. BOX/10, CE UROWIRE FDA UDI

Identifiers

Primary DI / UDI-DI
00607915111663 FDA UDI
FDA Product Code
KNY FDA UDI
EZB FDA UDI
ODC FDA UDI
DXT FDA UDI
EYB FDA UDI
GMDN Term
Gastro-urological guidewire, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Acucise® Endopyelotomy System 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

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI c94f427d-4fe7-420f-b9d3-d4695844182d 35 fields · synced May 30, 2026