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Lap Chole - Standard

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
LAP CHOLE - STANDARD FDA UDI
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX FDA UDI
Model / Reference
K2427 FDA UDI
Description
Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF03, 5x100 Kii® Fios® Z-THR 6/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX FDA UDI

Identifiers

Primary DI / UDI-DI
30607915131419 FDA UDI
FDA Product Code
GCJ FDA UDI
HET FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI

Classification

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

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

Category: Ligation clip, metallicLaparoscopic access cannula, single-useEndoscopic electrosurgical handpiece/electrode, monopolar, single-useTissue extraction bag

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

Similar devices

Also classified as Spring-loaded pneumoperitoneum needle, single-use.

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 76d6a8a4-bd4f-4e50-a0b1-d75365cd242a 34 fields · synced Jun 8, 2026