Ke116 Cole Completo

FDA UDI

Class I (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: KE116 COLE COMPLETO FDA UDI
Generic Name: Rigid endoscopic grasping forceps, single-use FDA UDI
Device Name: Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX FDA UDI
Model / Reference: GK233 FDA UDI
Description: Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CTF33, 11x100 Kii Fios ZTHR 6/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915130774 FDA UDI
FDA Product Code: NWV FDA UDI
FHF FDA UDI
HET FDA UDI
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Rigid endoscopic grasping forceps, single-use FDA UDI

Classification

Device Class: Class I 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 Rigid endoscopic grasping forceps, single-use

Ke116 Cole Completo by Applied Medical Resources Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 50d52413-9c97-4145-938d-cabfcbe963bd 34 fields · synced May 30, 2026