← Back to catalogue

Orthofix

FDA UDI

Class I (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name
ORTHOFIX FDA UDI
Generic Name
Surgical torque wrench, single-use FDA UDI
Device Name
ALLEN WRENCH 3MM STERILE FDA UDI
Model / Reference
1 FDA UDI
Description
ALLEN WRENCH 3MM STERILE FDA UDI

Identifiers

Catalog Number
99-10013 FDA UDI
Primary DI / UDI-DI
18059015370720 FDA UDI
FDA Product Code
HXC FDA UDI
GMDN Term
Surgical torque wrench, 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Width — 3 Millimeter FDA UDI

Category: Surgical torque wrench, single-use

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

Similar devices

Also classified as Surgical torque wrench, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Orthofix, Inc.

Sources (1)

  • FDA UDI 4240a110-3fd1-4ab8-b840-d7b1f47d4a47 36 fields · synced Jun 1, 2026