Vitalitec Clip Appliers

FDA UDI

Class I (US FDA UDI)

by Vitalitec International, Inc.

Identity

Trade Name: Vitalitec Clip Appliers FDA UDI
Generic Name: Open-surgery ligation clip applier FDA UDI
Device Name: PL528-1 (SM/MED CLIP APPLIER; 28cm Length) FDA UDI
Model / Reference: PL528-1 FDA UDI
Description: PL528-1 (SM/MED CLIP APPLIER; 28cm Length) FDA UDI

Identifiers

Primary DI / UDI-DI: 00850001784115 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

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 28 Centimeter FDA UDI

Category: Open-surgery ligation clip applier

The Vitalitec Clip Appliers is a hand-held, manual surgical instrument designed to apply small, atraumatic clips for the ligation of blood vessels or similar tubular anatomy. It may also be used to apply small clamps to tissues, but it is not intended to apply aneurysm clips. This reusable device is typically 28cm in length and features flat, curved ends to hold and deliver clips.

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
WECK — TELEFLEX INCORPORATED · Class I
S.C.A — SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ · 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

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Manufacturer

Manufacturer: Vitalitec International, Inc.

Sources (1)

FDA UDI a6591393-84ae-46cf-ab71-cf3b43fe8ac0 35 fields · synced Oct 7, 2026