Lap Chole Kit - Gardner, Sasse

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: LAP CHOLE KIT - GARDNER, SASSE FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX FDA UDI
Model / Reference: K2200 FDA UDI
Description: Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C0R47, 12x100 Kii® BALLOON BLUNT TIP 6/BX CTR03, 5x100 Kii® OPT ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CTR33, 11X100 Kii® OPT ZTHR 6/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 30607915126361 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 - Gardner, Sasse by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI ce92d8cf-ab84-45c7-9e8c-ade848148a6b 34 fields · synced May 30, 2026