LAP CHOLE KIT - 10mm

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: LAP CHOLE KIT - 10mm FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFR03, 5X100 Kii® OPT ADVFIX 6/BX CFR33, 11X100 Kii® OPT ADVFIX 6/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX FDA UDI
Model / Reference: K2383 FDA UDI
Description: Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFR03, 5X100 Kii® OPT ADVFIX 6/BX CFR33, 11X100 Kii® OPT ADVFIX 6/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 30607915130887 FDA UDI
FDA Product Code: GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Laparoscopic access cannula, single-use 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

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 - 10mm 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 2793aaa0-ca88-4e36-9c13-b75c133f2a24 34 fields · synced Jun 1, 2026