FDA UDI
In Commercial Distribution
🇺🇸 United States
nanOss 3D Plus Advanced Bone Graft Substitute
DI: 00849777012522
·
Model: 90-400-25504
·
Xtant Medical Holdings, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- nanOss 3D Plus Advanced Bone Graft Substitute
- Primary DI
- 00849777012522
- Version / Model
- 90-400-25504
- Catalog Number
- 90-400-25504
- Company Name
- Xtant Medical Holdings, Inc.
- Labeler DUNS
- 081224143
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-04-16
- Public Version
- 2
- Public Version Date
- 2025-04-07
- Public Version Status
- Update
- Public Device Record Key
- baec2b52-8207-42e1-b428-26ac7a3a2d7c
Device Description
Advanced Bone Graft Substitute 5cc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 47967 | Bone matrix implant, composite | A sterile bioabsorbable device made of synthetic bone substitute materials (e.g., ceramics such as tricalcium phosphate or hydroxyapatite) combined with bone growth factors (e.g., bovine collagen) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill cystic defects, repair fractures, and/or extend autogenous bone grafts. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849777012522 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K132050 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 1 – 37 Degrees Celsius