FDA UDI
In Commercial Distribution
🇺🇸 United States
OSTEO-MESH TM-300
DI: D765TM253410
·
Model: TM2534
·
Osteogenics Biomedical Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OSTEO-MESH TM-300
- Primary DI
- D765TM253410
- Version / Model
- TM2534
- 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
- 4
- Public Version Date
- 2020-12-07
- Public Version Status
- Update
- Public Device Record Key
- 00f10bc8-6dda-4f1b-81a6-3f6f50497f80
Device Description
Titanium Ridge Augmentation Mesh, 25mm x 34mm, Nonsterile, Contents: 1 Mesh
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 Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JEY | Plate, Bone | Dental | 872.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48004 | Dental bone matrix implant, metallic | A sterile non-bioabsorbable device made of metal and/or metal oxide [e.g., titanium (Ti)] 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 typically used to fill bone cavities and defects to promote the ingrowth of endogenous bone for skeletal reconstruction and/or augmentation. It is typically available as porous granules. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D765TM253410 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 34 | Millimeter | |
| Width | 25 | Millimeter |