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Kit Ke167 Cole

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name
KIT KE167 COLE FDA UDI
Generic Name
Laparoscopic electrosurgical blunt dissector 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 CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX FDA UDI
Model / Reference
GK242 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 CY010, 5mmX35cm EPIX LAPA DISSECT, 10/BX FDA UDI

Identifiers

Primary DI / UDI-DI
20607915131245 FDA UDI
FDA Product Code
FHF FDA UDI
GEI FDA UDI
HET FDA UDI
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term
Laparoscopic electrosurgical blunt dissector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.4370 FDA UDI
878.4400 FDA UDI
884.1720 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

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-useSpring-loaded pneumoperitoneum needle, single-use

Kit Ke167 Cole by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Laparoscopic electrosurgical blunt dissector.

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 e71e36a7-1ac5-4fe8-81b8-07fc03cb6aa6 34 fields · synced May 30, 2026