FDA UDI
In Commercial Distribution
🇺🇸 United States
REGENEROSS®
DI: 00844868028239
·
Model: ROAPM10
·
ZimVie US Corp LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- REGENEROSS®
- Primary DI
- 00844868028239
- Version / Model
- ROAPM10
- Company Name
- ZimVie US Corp LLC
- Labeler DUNS
- 119287313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-24
- Public Version
- 4
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- b705ebe7-491b-49f2-9b41-a2de49b37a43
Device Description
DBM AND MINERALIZED ALLOGRAFT IN A LECITHIN CARRIER
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NUN | BONE GRAFTING MATERIAL, HUMAN SOURCE | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47970 | Dental bone matrix implant, human-derived | A 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 augment/reconstruct maxillofacial and/or mandibular bone by filling bone voids or gaps caused by trauma or dental surgery. It is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is typically available in the form of a sterile powder, crushed granules, putty, chips, or gel injected with syringe. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00844868028239 | GS1 |
Customer Contacts
- Phone
- +1(800)342-5454
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Volume 1 mL |