AccessGUDID - DEVICE: PlatFORM CM Strip (00813954021867)

GUDID

Device Identifier (DI) Information

Brand Name: PlatFORM CM Strip
Version or Model: CM46405
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COLLAGEN MATRIX, INC.

Primary DI Number: 00813954021867
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176262442 *Terms of Use
Previous DI: 00813954021003

Device Description: Collagen Mineral Bone Graft Matrix 5cc

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?
46543	Composite bone graft	An implantable device that combines various bone substitute materials and/or bone growth factors to serve as a structural bone replacement typically when bone is lost due to trauma or osteoporosis. It is available in a variety of combinations such as collagen/ceramic, or polytetrafluoroethylene (PTFE) with carbon fibres.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MQV	Filler, Bone Void, Calcium Compound

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
Device Size Text, specify: 5cc

Device Record Status

Public Device Record Key: 2cafe545-47a5-40d4-8ff9-06a90c8a5ef1
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 01, 2016