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Gauthier Biomedical

FDA UDI

Class I (US FDA UDI)

by Gauthier Biomedical, Inc.

Identity

Trade Name
Gauthier Biomedical FDA UDI
Generic Name
Orthopaedic surgical distractor, internal FDA UDI
Device Name
COMPRESSOR 5.5/6.0, PARALLEL FDA UDI
Model / Reference
5161-00-5051 (G601227) FDA UDI
Description
COMPRESSOR 5.5/6.0, PARALLEL FDA UDI

Identifiers

Catalog Number
5161005051 FDA UDI
Primary DI / UDI-DI
00858325005695 FDA UDI
FDA Product Code
HWN FDA UDI
GMDN Term
Orthopaedic surgical distractor, internal 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic surgical distractor, internal

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

Similar devices

Also classified as Orthopaedic surgical distractor, internal.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gauthier Biomedical, Inc.

Sources (1)

  • FDA UDI 5aa829d9-d1db-4e24-b54e-45dba6c234d3 35 fields · synced Jun 8, 2026