FDA UDI
In Commercial Distribution
🇺🇸 United States
Current
DI: 10889981180461
·
Model: 02-9000-010
·
ISOTIS ORTHOBIOLOGICS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Current
- Primary DI
- 10889981180461
- Version / Model
- 02-9000-010
- Catalog Number
- 02-9000-010
- Company Name
- ISOTIS ORTHOBIOLOGICS, INC.
- Labeler DUNS
- 801089152
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-28
- Public Version
- 1
- Public Version Date
- 2019-11-05
- Public Version Status
- New
- Public Device Record Key
- 9b5f99ef-24f9-4d5f-9b07-2d410cea466e
Device Description
Current, 1cc
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- 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
- 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 | 10889981180461 | GS1 |
Customer Contacts
- Phone
- +1(800)550-7155
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181958 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1cc |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- High: 45 Degrees Celsius