Lap Chole /osu East

FDA UDI

Class II (US FDA UDI)

by Applied Medical Resources Corp.

Identity

Trade Name: LAP CHOLE /OSU EAST FDA UDI
Generic Name: Surgical irrigation/aspiration tubing set FDA UDI
Device Name: Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFF73, 12x100 Kii® Fios® ADVFIX 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C7100, EPIX® SI CARTRIDGE SET, 12/BX FDA UDI
Model / Reference: K2848 FDA UDI
Description: Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CFF03, 5x100 Kii® Fios® ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFF73, 12x100 Kii® Fios® ADVFIX 6/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CB030, 5mmx35cm EPIX® LAPA SCISSOR, 10/BX C7100, EPIX® SI CARTRIDGE SET, 12/BX FDA UDI

Identifiers

Primary DI / UDI-DI: 20607915136066 FDA UDI
FDA Product Code: BTA FDA UDI
HET FDA UDI
GCJ FDA UDI
FZP FDA UDI
MDM FDA UDI
GMDN Term: Surgical irrigation/aspiration tubing set FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4780 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

Lap Chole /osu East by Applied Medical Resources Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical irrigation/aspiration tubing set.

LAMIS Tubing — Mentor Texas LP · Class I
Aspiration Tubing — BLACK & BLACK SURGICAL, INC. · Class II
MB ULTRA-LIMP TUBING — The Wells Johnson Company · Class II
INFILTRATION TUBING — BLACK & BLACK SURGICAL, INC. · Class II
Autofuse Tubing — Mentor Texas LP · Class I
Medline — MEDLINE INDUSTRIES, INC. · Class II
ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
Hysteroscopy set 2 spikes — Promepla · 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 b89e0891-5d58-4a14-8116-393db8f99dba 34 fields · synced Jun 6, 2026