Grappler™ Suture Anchor System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: Grappler™ Suture Anchor System FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: BridgeLine Suture Tape, 4mm, UHMWPE/PGLA, Sterile FDA UDI
Model / Reference: P44-310-0004-S FDA UDI
Description: BridgeLine Suture Tape, 4mm, UHMWPE/PGLA, Sterile FDA UDI

Identifiers

Catalog Number: P44-310-0004-S FDA UDI
Primary DI / UDI-DI: 00889795114334 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Suturing unit, single-use

Grappler™ Suture Anchor System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Paragon 28

Sources (1)

FDA UDI 6c1d1b30-762d-4ca1-8572-aa52504f955c 34 fields · synced May 30, 2026