DBM A41120 1CC GRAFTON GEL

DBM A41120 1CC GRAFTON GEL
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) - A41120

An sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

No Data Available

• 1 cc volume

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MQV

Device Name: Filler, Bone Void, Calcium Compound

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3045

Third Party Flag: N

Medical Specialty: OR

Code: MBP

Device Name: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: OR

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: Y

Target Area: N/A

Regulation Number: 888.3045

Third Party Flag: N

Medical Specialty: OR

Device Id: 00613994986023

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A