FDA UDI
In Commercial Distribution
🇺🇸 United States
RPM™ Reinforced PTFE Mesh
DI: D765RPM200ATC0
·
Model: RPM200ATC
·
Osteogenics Biomedical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- RPM™ Reinforced PTFE Mesh
- Primary DI
- D765RPM200ATC0
- Version / Model
- RPM200ATC
- Company Name
- Osteogenics Biomedical Inc
- Labeler DUNS
- 123853058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-27
- Public Version
- 2
- Public Version Date
- 2024-01-30
- Public Version Status
- Update
- Public Device Record Key
- 24a67ebd-8f23-4473-aa43-b52e8789abfc
Device Description
RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.
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 |
|---|---|---|---|---|
| NPK | Barrier, Synthetic, Intraoral | Dental | 872.3930 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66253 | Dental/maxillofacial surgical mesh, metal/polymer | A non-bioabsorbable, implantable, woven/knitted porous material made of both a synthetic polymer(s) and metal (typically a synthetic polymer covered metal frame) intended to provide temporary stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D765RPM200ATC0 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171774 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 38 | Millimeter | |
| Width | 24 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit