DBX®
| Catalog Number: | 038005 |
|---|---|
| Company Name: | Musculoskeletal Transplant Foundation, Inc. |
| Device Combination Product: | N/A |
| Device Commercial Dsitribution End Date: | N/A |
| Device Commercial Dsitribution Status: | In Commercial Distribution |
| Device Count: | 1 |
| Device Description: | DBX Putty, 0.5cc |
| Device hctp: | true |
| Device kit: | N/A |
| Device Publish Date: | 2016-02-19 |
| Device Record Status: | Published |
| Direct Market Exempt: | N/A |
| Has Donation ID number? | true |
| DUNS Number: | 187560545 |
| Has Expiration Date? | true |
| Is Labelled as NRL: | N/A |
| Is Labelled As No NRL: | N/A |
| Has Lot Batch Number: | true |
| Has Manufacutring Date: | N/A |
| MRI Safety Status: | Labeling does not contain MRI Safety Information |
| Is OTC? | N/A |
| Is Devic Premarket Exempt: | N/A |
| Public Device Record Key: | a4207896-01a2-4b4b-8be4-33a58c4d16bf |
| Public Version Date: | 2018-03-29 |
| Public Version Number: | 2 |
| Public Version Status: | Update |
| Is Rx? | true |
| Has Serial Number? | N/A |
| Is Single Use: | true |
| Version Model Number: | 038005 |
| Adress: | Phone:800-433-6576 Extension: Email: RA_Licenses@mtf.org |
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term 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.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
W4184038005T0473
Primary
ICCBBA
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
false
Product Codes
Product Code
Product Code Name
GXP
Methyl Methacrylate For Cranioplasty
MQV
Filler, Bone Void, Calcium Compound
Pre Market Submisison
Submission Number
Supplement Number
N/A
N/A