DEVICE: NA (07613327176957)
Device Identifier (DI) Information
NA
3102-1205
In Commercial Distribution
3102-1205
Stryker Corporation
3102-1205
In Commercial Distribution
3102-1205
Stryker Corporation
Allograft DBM Plus Paste with Cancellous
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
Yes |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Bone matrix implant, human-derived | 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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MBP | Filler, bone void, osteoinduction (w/o human growth factor) |
MQV | FILLER, BONE VOID, CALCIUM COMPOUND |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: Total Volume: 5.0 Cubic Centimeter |
Device Record Status
363dcdad-2ef1-4dc3-aba3-3caf87ea89b8
March 29, 2018
2
October 24, 2015
March 29, 2018
2
October 24, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined