INFINITY™ Occipitocervical Upper Thoracic System

FDA UDI

Class I (US FDA UDI)

by Medtronic Sofamor Danek, Inc.

Identity

Trade Name: INFINITY™ Occipitocervical Upper Thoracic System FDA UDI
Generic Name: Surgical torque wrench, reusable FDA UDI
Device Name: COUNTERTORQUE 3606178 SEQUENTIAL FDA UDI
Model / Reference: 3606178 FDA UDI
Description: COUNTERTORQUE 3606178 SEQUENTIAL FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000959975 FDA UDI
FDA Product Code: HXC FDA UDI
GMDN Term: Surgical torque wrench, reusable 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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Surgical torque wrench, reusable

INFINITY™ Occipitocervical Upper Thoracic System by Medtronic Sofamor Danek, Inc. — Class I — 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 I	Pending data

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Manufacturer

Manufacturer: Medtronic Sofamor Danek, Inc.

Sources (1)

FDA UDI 6f5b9cd6-aca1-40ac-afc6-456c38d195fb 34 fields · synced Jun 8, 2026