← Back to catalogue

Acucise® Procedural Pack

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
ACUCISE® PROCEDURAL PACK FDA UDI
Generic Name
Ureteral stent-placement set FDA UDI
Device Name
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3305, STENT, C-FLEX 7/10F x 22 CM FDA UDI
Model / Reference
BK022 FDA UDI
Description
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3305, STENT, C-FLEX 7/10F x 22 CM FDA UDI

Identifiers

Primary DI / UDI-DI
20607915128177 FDA UDI
FDA Product Code
FAD FDA UDI
FED FDA UDI
KNY FDA UDI
EZB FDA UDI
DXT FDA UDI
EYB FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term
Ureteral stent-placement set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4620 FDA UDI
876.1500 FDA UDI
876.5130 FDA UDI
870.1650 FDA UDI
878.4300 FDA UDI
878.4800 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® Procedural 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI 54ec5614-4a20-4857-954a-827dc1215b55 35 fields · synced Jun 1, 2026