Am- Chole Kit- Port Mac Q

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: AM- CHOLE KIT- PORT MAC Q FDA UDI
Generic Name: Laparoscopic access cannula, single-use FDA UDI
Device Name: Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX FDA UDI
Model / Reference: K0592 FDA UDI
Description: Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTF12, 5x100 Kii® Fios® ZTHR DP 10/BX CTF33, 11x100 Kii® Fios® ZTHR 6/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 30607915120499 FDA UDI
FDA Product Code: GCJ FDA UDI
FHF FDA UDI
HET FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Laparoscopic access cannula, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 FDA UDI
876.4370 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

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 Laparoscopic irrigation/aspiration cannula

Am- Chole Kit- Port Mac Q 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 0f4c48fa-dad4-4314-ae87-c59220ae7cf0 34 fields · synced Jun 1, 2026