Parcus Suture Tape

FDA UDI

Class II (US FDA UDI)

by Parcus Medical Llc

Identity

Trade Name: Parcus Suture Tape FDA UDI
Generic Name: Polyolefin/fluoropolymer suture, multifilament FDA UDI
Model / Reference: 20042 FDA UDI

Identifiers

Catalog Number: 20042 FDA UDI
Primary DI / UDI-DI: M685200421 FDA UDI
510(k) Number: K153307 FDA UDI
FDA Product Code: GAT FDA UDI
GMDN Term: Polyolefin/fluoropolymer suture, multifilament FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5000 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Polyolefin/fluoropolymer suture, multifilament

Parcus Suture Tape by Parcus Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Polyolefin/fluoropolymer suture, multifilament.

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FORCE FIBER — TELEFLEX INCORPORATED · Class II
Arthrex® — Arthrex, Inc. · Class II
HI-FI — TELEFLEX INCORPORATED · Class II
FORCE FIBER — TELEFLEX INCORPORATED · Class II
CuffCable — RIVERPOINT MEDICAL LLC · Class II

Cleared under the same submission

K153307 also covers:

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: Parcus Medical Llc

Sources (1)

FDA UDI d8d90bfe-f5ce-4431-84fc-011a9b90d097 35 fields · synced May 30, 2026