FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSIX® Breeze
DI: 07290015477307
·
Model: 68018004
·
DATUM DENTAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- OSSIX® Breeze
- Primary DI
- 07290015477307
- Version / Model
- 68018004
- Company Name
- DATUM DENTAL LTD
- Labeler DUNS
- 600170232
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-05
- Public Version
- 1
- Public Version Date
- 2022-09-13
- Public Version Status
- New
- Public Device Record Key
- f33e304c-1d70-4349-bf6d-e24189fe339c
Device Description
Cross-linked pericardium membrane
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 |
|---|---|---|---|---|
| NPL | Barrier, Animal Source, Intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58709 | Collagen dental regeneration membrane | A sterile bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, and to regenerate bone defects around implants and at sites intended for implant placement, by acting as a barrier to prevent the down-growth of soft tissue into the underlying bone during the healing period. It is a pliable material made of animal-derived collagen (e.g., porcine) which may be fixed to soft tissues with sutures; it is applied between soft tissue and bone during periodontal flap surgery and applied to grafted bone defects in guided bone regeneration (GBR) and guided tissue regeneration (GTR) procedures. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290015477307 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212509 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 10 | Millimeter | |
| Length | 12 | Millimeter |