FDA UDI
In Commercial Distribution
🇺🇸 United States
Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced
DI: D765TI250AP20
·
Model: Ti250AP-2
·
Osteogenics Biomedical Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Cytoplast™ Non-Resorbable PTFE Barrier Membranes, Titanium-Reinforced
- Primary DI
- D765TI250AP20
- Version / Model
- Ti250AP-2
- Company Name
- Osteogenics Biomedical Inc
- Labeler DUNS
- 123853058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-29
- Public Version
- 5
- Public Version Date
- 2020-12-07
- Public Version Status
- Update
- Public Device Record Key
- 98bfece3-f4de-44c2-a0d6-5171407c254a
Device Description
Nonresorbable Textured PTFE Barrier Membrane, Titanium-Reinforced, 13 mm x 19 mm
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62481 | Pliable-polymer dental regeneration membrane, non-bioabsorbable | A sterile non-bioabsorbable material intended to be used to aid in the regeneration of tooth support, lost due to periodontal disease or trauma, by acting as a barrier to prevent the down-growth of soft tissue (connective tissue and epithelial cells) into the underlying bone during the healing period. It is a pliable synthetic polymer material that is held in place between soft tissue and bone [e.g., with ligatures, sutures, or pins (may be attached/included)] and applied during periodontal flap surgery and other guided bone regeneration (GBR) and guided tissue regeneration (GTR) surgical procedures. A plasticizer to soften the membrane may be included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D765TI250AP20 | HIBCC | ||||
| Package | D765TI250AP21 | HIBCC | Box | 2 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 19 | Millimeter | |
| Width | 13 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius