AccessGUDID - DEVICE: OssiMend® Bioactive

GUDID

Device Identifier (DI) Information

Brand Name: OssiMend® Bioactive | Putty
Version or Model: MCCBAM20
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCCBAM20
Company Name: COLLAGEN MATRIX, INC.

Primary DI Number: 00813954026299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 176262442 *Terms of Use

Device Description: Moldable Bone Graft Matrix

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?
46425	Bone matrix implant, animal-derived, bioabsorbable	A sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.	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
Storage Environment Temperature: between 59 and 86 Degrees Fahrenheit
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20cc, 5.0cm x 5.0cm x 0.8cm

Device Record Status

Public Device Record Key: 3cf43e50-8026-4a0a-ac65-1648f333bbf0
Public Version Date: September 24, 2024
Public Version Number: 1
DI Record Publish Date: September 16, 2024