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Acucise® Procedural Pack Universal Pack D

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
ACUCISE® PROCEDURAL PACK UNIVERSAL PACK D FDA UDI
Generic Name
Ureteral stent-placement set FDA UDI
Device Name
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX FDA UDI
Model / Reference
BK005 FDA UDI
Description
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3304, STENT, C-FLEX 7/10F x 24 CM B3301, STENT, C-FLEX, 7/10F X 26CM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX FDA UDI

Identifiers

Primary DI / UDI-DI
20607915128153 FDA UDI
FDA Product Code
DXT FDA UDI
KNY FDA UDI
EZB FDA UDI
EYB FDA UDI
FED FDA UDI
FAD FDA UDI
GMDN Term
Ureteral stent-placement set FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 FDA UDI
876.5130 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

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 Universal Pack D 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 cd4a0ebd-de6d-43a3-8729-a7b61a4cc9de 35 fields · synced Jun 8, 2026