ArthroPass

FDA UDI

Class I (US FDA UDI)

by Tornier, Inc.

Identity

Trade Name: ArthroPass FDA UDI
Generic Name: Suturing needle, single-use FDA UDI
Device Name: SUTURE PASSER NEEDLE FDA UDI
Model / Reference: 0846832010448 FDA UDI
Description: SUTURE PASSER NEEDLE FDA UDI

Identifiers

Catalog Number: 0846832010448 FDA UDI
Primary DI / UDI-DI: 00846832010448 FDA UDI
FDA Product Code: GAB FDA UDI
GMDN Term: Suturing needle, single-use 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

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

Category: Suturing needle, single-use

ArthroPass by Tornier, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Suturing needle, single-use.

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Richard-Allan® Needle 1/2 Circle Reverse Cutting — Aspen Surgical Products, Inc. · Class I
RC Needle — Biomet Orthopedics, Inc. · Class I
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RC NEEDLE — 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: Tornier, Inc.

Sources (1)

FDA UDI a32b17af-0cea-4cec-b49b-5631d20196f9 35 fields · synced May 30, 2026