AccessGUDID - DEVICE: OsteoBridge™ IDSF Diaphysis Spacer (04048266000101)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoBridge™ IDSF Diaphysis Spacer
Version or Model: 30 50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GB03005
Company Name: Merete GmbH

Primary DI Number: 04048266000101
Issuing Agency: GS1
Commercial Distribution End Date: June 01, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 313267265 *Terms of Use

Device Description: TiAl6V4 ELI sterile

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:	Yes
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?
58084	Diaphysis prosthesis	An artificial substitute for the diaphysis (shaft) of a humerus, femur, or tibia intended to be implanted for the long-term stabilization of segmental bone defects (e.g., due to osteomyelitis, trauma, bone tumours, or non-healed fractures after osteosynthesis/revision arthroplasty). It is a modular device that typically includes a resection element (spacer), intramedullary nails (inserted into the intramedullary canal), screws, and connectors all made of metal [e.g., titanium (Ti)]; components are both sterile and non-sterile. Instruments for implantation are typically included and implantation may be performed with or without bone cement.	Active	true

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 50 Millimeter
Outer Diameter: 30 Millimeter

Device Record Status

Public Device Record Key: 2d3a0867-68e0-44ea-a734-a9c8c4546737
Public Version Date: July 04, 2023
Public Version Number: 5
DI Record Publish Date: October 15, 2015