Kit Ke214 Cole

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: KIT KE214 COLE FDA UDI
Generic Name: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use FDA UDI
Device Name: Kit Contains: CTB35, 11x100 Kii SH BLD Z-THRD DP 10/BX CTB03, 5x100 Kii SH BLD ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX FDA UDI
Model / Reference: GK265 FDA UDI
Description: Kit Contains: CTB35, 11x100 Kii SH BLD Z-THRD DP 10/BX CTB03, 5x100 Kii SH BLD ZTHR 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915135724 FDA UDI
FDA Product Code: HET FDA UDI
FHF FDA UDI
GCJ 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: 884.1720 FDA UDI
876.4370 FDA UDI
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 Endoscopic electrosurgical handpiece/electrode, monopolar, single-use Spring-loaded pneumoperitoneum needle, single-use

Kit Ke214 Cole by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic irrigation/aspiration cannula.

MicroLap Irrigation Tube Dolphin L=200MM — Medica Corp. · Class II
PTFE coated cannula Ø 5 mm, 450 mm for irrigation/suction system, single use — Medica Corp. · Class II
Modulap — ATC TECHNOLOGIES INC. · Class II
Sklar® — Sklar Corporation · Class II
Sklar® — Sklar Corporation · Class II
Modulap — ATC TECHNOLOGIES INC. · Class II
Sklar® — Sklar Corporation · Class II
PTFE coated cannula Ø 10 mm, 330 mm for irrigation/suction system, single use — Medica Corp. · 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 8deebb8c-6ee3-486a-b913-2c569a7e46ac 34 fields · synced May 30, 2026