FDA UDI
In Commercial Distribution
🇺🇸 United States
DirectOss™
DI: 10841307122500
·
Model: DXCA102025
·
IMPLANT DIRECT SYBRON MANUFACTURING LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DirectOss™
- Primary DI
- 10841307122500
- Version / Model
- DXCA102025
- Catalog Number
- DXCA102025
- Company Name
- IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Labeler DUNS
- 868856969
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 9ab72f64-6fd5-404e-b3c0-a42536054eca
Device Description
Anorganic Bovine Cancellous Bone (1000-2000µm) - 0.25g
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
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NPM | Bone Grafting Material, Animal Source | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47968 | Dental bone matrix implant, animal-derived | A sterile bioabsorbable device made primarily of animal-derived bone or dentin matrix (e.g., bovine, porcine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace maxillofacial and/or mandibular bone lost through trauma or dental surgery. It is used to fill bone cavities and defects and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically provided as sterile 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 | 10841307122500 | GS1 |
Customer Contacts
- Phone
- 1-888-649-6425
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151209 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1000-2000µm, 0.25g |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Room Temperature (15°C/59°F to 25°C/77°F)