AccessGUDID - DEVICE: FITBONE® (04260170140586)

GUDID

Device Identifier (DI) Information

Brand Name: FITBONE®
Version or Model: DUMM TAA1140-T-205
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 60001244
Company Name: WITTENSTEIN intens GmbH

Primary DI Number: 04260170140586
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 315887799 *Terms of Use

Device Description: Dummy TAA1140-T-205

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47901	Bone nail trial, reusable	A copy of a final orthopaedic bone nail designed to be introduced into the bone (e.g., proximal and/or distal end of the intramedullary canal of a long bone) to function as a reference for the subsequent introduction of the final bone nail, and typically also guide wire and/or bone screws. It is typically used in conjunction with appropriate holders/positioning devices (not included). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 11 Millimeter
Length: 205 Millimeter

Device Record Status

Public Device Record Key: bff06ce1-5f4e-4495-aa06-17d875460f1b
Public Version Date: March 06, 2025
Public Version Number: 7
DI Record Publish Date: December 12, 2017