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Soft tissue gauge 6 mm

FDA UDI

Class I (US FDA UDI)

by Cochlear Bone Anchored Solutions AB

Identity

Trade Name
Soft tissue gauge 6 mm FDA UDI
Generic Name
General external orthopaedic fixation system implantation kit, reusable FDA UDI
Device Name
N/A FDA UDI
Model / Reference
95070 FDA UDI
Description
N/A FDA UDI

Identifiers

Catalog Number
95070 FDA UDI
Primary DI / UDI-DI
09321502027090 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
General external orthopaedic fixation system implantation kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 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

No

FDA UDI

Dimensions & Sizes

Size
Length — 6 Millimeter FDA UDI

Category: General external orthopaedic fixation system implantation kit, reusable

Soft tissue gauge 6 mm by Cochlear Bone Anchored Solutions AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General external orthopaedic fixation system implantation kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cochlear Bone Anchored Solutions AB

Sources (1)

  • FDA UDI c215e53d-193b-48a2-9311-95f5ca3bf7f4 36 fields · synced Jun 1, 2026