← Back to catalogue

Gibralt

FDA UDI

Class U (US FDA UDI)

by Choicespine, LP

Identity

Trade Name
Gibralt FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Model / Reference
05-000-04-4042 FDA UDI

Identifiers

Catalog Number
05-000-04-4042 FDA UDI
Primary DI / UDI-DI
10885862176349 FDA UDI
FDA Product Code
MRW FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4.0 Millimeter FDA UDI
Length — 42 Millimeter FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

Gibralt by Choicespine, LP — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

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
Choicespine, LP

Sources (1)

  • FDA UDI 4ca906eb-adfe-4690-9186-fba137e126c9 34 fields · synced Jun 1, 2026