GeniClip Applier

FDA UDI

Class I (US FDA UDI)

by Genicon

Identity

Trade Name: GeniClip Applier FDA UDI
Generic Name: Open-surgery ligation clip applier FDA UDI
Model / Reference: 350-010-001 FDA UDI

Identifiers

Primary DI / UDI-DI: 00877972004417 FDA UDI
FDA Product Code: HBT FDA UDI
GMDN Term: Open-surgery ligation clip applier FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Open-surgery ligation clip applier

GeniClip Applier by Genicon — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Open-surgery ligation clip applier.

WECK — TELEFLEX INCORPORATED · Class I
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · Class I
WECK — TELEFLEX INCORPORATED · Class I
WECK — TELEFLEX INCORPORATED · Class I
AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class I
Vitalitec Clip Appliers — VITALITEC INTERNATIONAL, INC. · Class I
WECK — TELEFLEX INCORPORATED · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Genicon

Sources (1)

FDA UDI 466d0682-b757-45e0-9d85-5b810b198840 32 fields · synced Jun 6, 2026