Grappler Interference Screw System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Grappler Interference Screw System FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: Blind-Tunnel Suture Loop Guide Rod w/ Nitinol Loop FDA UDI
Model / Reference: P41-960-0030 FDA UDI
Description: Blind-Tunnel Suture Loop Guide Rod w/ Nitinol Loop FDA UDI

Identifiers

Catalog Number: P41-960-0030 FDA UDI
Primary DI / UDI-DI: 00889795107565 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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Suturing unit, single-use

Grappler Interference Screw System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 124f4b56-8ec8-4818-bb4d-aadd4ed07c6d 34 fields · synced May 30, 2026