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Fitbone® Tube T12/09-S

by Wittenstein Intens GmbH GUDID

Listed FDA GUDID listing, not in commercial distribution

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04260170140975 UDI-DIDate12 Dec 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Fitbone®
Generic Name
Orthopaedic implantation sleeve, reusable
Model / Ref / Catalog
TUBE T12/09-S, 60001048
Primary DI / UDI-DI
04260170140975
FDA Product Code
HSB
GMDN Term
Orthopaedic implantation sleeve, reusable
Device Class
Class II
Regulation Number
888.3020
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Lumen/Inner Diameter — 9 Millimeter
Outer Diameter — 12 Millimeter

Other devices from Wittenstein Intens GmbH

  • Fitbone Taa

    Class II

  • Fitbone(R) Taa

    Class II

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No