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Lap Chole Procedure Pack

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
LAP CHOLE PROCEDURE PACK FDA UDI
Generic Name
Spring-loaded pneumoperitoneum needle, single-use FDA UDI
Device Name
Kit Contains: CA090, DIRECT DRIVE LCA 3/BX CTR33, 11X100 Kii OPT ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTR03, 5x100 Kii OPT ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX FDA UDI
Model / Reference
GK128 FDA UDI
Description
Kit Contains: CA090, DIRECT DRIVE LCA 3/BX CTR33, 11X100 Kii OPT ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CTR03, 5x100 Kii OPT ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX FDA UDI

Identifiers

Primary DI / UDI-DI
20607915136202 FDA UDI
FDA Product Code
HET FDA UDI
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term
Spring-loaded pneumoperitoneum needle, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1720 FDA UDI
876.1500 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

Lap Chole Procedure 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

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Manufacturer

Manufacturer
Applied Medical Resources Corp.

Sources (1)

  • FDA UDI 4affadb0-55c8-40ff-803c-031541df884e 35 fields · synced May 31, 2026