PlatFORM CM Strip

Basic Information

• Brand Name: PlatFORM CM Strip
• Primary DI: 10813954021840
• Version / Model: CM46420
• Company Name: COLLAGEN MATRIX, INC.
• Labeler DUNS: 176262442
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-08-01
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: a221c478-c70e-43e1-8aba-a08f38f511c1

Device Description

Collagen Mineral Bone Graft Matrix 20cc (Packaged as two 10cc Strips)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	888.3045	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10813954021840	GS1
Unit of Use	00813954021843	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			20cc