Chole Kit 24

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: CHOLE KIT 24 FDA UDI
Generic Name: Laparoscopic irrigation/aspiration cannula FDA UDI
Device Name: Kit Contains: C0R95, 12x100 Kii BLUNT TIP SM CONE 6/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX FDA UDI
Model / Reference: GK320 FDA UDI
Description: Kit Contains: C0R95, 12x100 Kii BLUNT TIP SM CONE 6/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTF12, 5x100 Kii Fios ZTHR DP 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 30607915135592 FDA UDI
FDA Product Code: FHF FDA UDI
HET FDA UDI
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Laparoscopic irrigation/aspiration cannula FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.4370 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

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 Tissue extraction bag

Chole Kit 24 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

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Manufacturer

Manufacturer: Applied Medical Resources Corp.

Sources (1)

FDA UDI 56d597d6-501d-466f-bbc0-b1e7cc379c78 34 fields · synced Jun 6, 2026