Lap Chole Kit-Mcnamara

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: LAP CHOLE KIT-MCNAMARA FDA UDI
Generic Name: Ligation clip, metallic FDA UDI
Device Name: Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CA090, DIRECT DRIVE® LCA 3/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX FDA UDI
Model / Reference: K2191 FDA UDI
Description: Kit Contains: CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CA090, DIRECT DRIVE® LCA 3/BX CTS12, 11x100 Kii® SLEEVE ZTHR 12/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 30607915126064 FDA UDI
FDA Product Code: GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Ligation clip, metallic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
878.4300 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Category: Ligation clip, metallic Laparoscopic access cannula, single-use

Lap Chole Kit-Mcnamara by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic access cannula, single-use.

Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
SECQURE Ultimate — SECQURE SURGICAL, CORP. · Class II
Secondary trocar with Gas Port + Additional Cannula without Gas Port — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
Auto-shield trocar, ribbed cannula — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
BluView — Unimax Medical Systems Inc. · Class II
Busse Hospital Disposables — ROBERT BUSSE & CO., INC. · Class II
Auto Shield Trocar, Ribbed, plus extra cannula — PURPLE SURGICAL INTERNATIONAL LIMITED · Class II
Versaport — Covidien LP · Class II

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

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

Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI a10ec132-a8b1-44bc-8131-051a78134d4e 34 fields · synced May 30, 2026