Grappler™ Suture Anchor System

FDA UDI

Class I (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: Suture Passer in pouch assembly FDA UDI
Model / Reference: P44-970-0001-S FDA UDI
Description: Suture Passer in pouch assembly FDA UDI

Identifiers

Catalog Number: P44-970-0001-S FDA UDI
Primary DI / UDI-DI: 00889795123954 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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 I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suturing unit, single-use.

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Arthrex® — Arthrex, Inc. · Class I
OverStitch NXT Endoscopic Suturing System — Apollo Endosurgery · Class II
SlingShot — Stryker Corp. · Class I
NanoPass — Stryker Corp. · Class I
DISPOSABLE NITINOL NDL SINGLE PACK — Biomet Orthopedics, Inc. · 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: Paragon 28

Sources (1)

FDA UDI 9be8a63a-9ad6-4692-88c2-43df182df768 34 fields · synced May 30, 2026