FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOGUARD®
DI: 00844868041535
·
Model: TIM4545-1
·
ZimVie US Corp LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- OSSEOGUARD®
- Primary DI
- 00844868041535
- Version / Model
- TIM4545-1
- Company Name
- ZimVie US Corp LLC
- Labeler DUNS
- 119287313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-31
- Public Version
- 6
- Public Version Date
- 2026-01-15
- Public Version Status
- Update
- Public Device Record Key
- 29b8d537-3f0b-4e2f-af04-a9c2f869db80
Device Description
OSSEOGUARD® TITANIUM RIDGE AUGMENTATION MESH 45 X 45
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
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 46580 | Extra-gynaecological surgical mesh, metal | A non-bioabsorbable, implantable material (e.g., flat sheet) made from made from a biocompatible metal, with appropriate mechanical characteristics for implantation, intended for an extra-gynaecological tissue repair/reinforcement application(s) to support or protect tissues in reconstructive surgical procedures (e.g., to repair large chest wall defects or large abdominal incisional hernias) and/or orthopaedic procedures (e.g., cranioplasty, femoral reconstruction); it is not primarily intended for dental use. 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 | 00844868041535 | GS1 |
Customer Contacts
- Phone
- +1(800)342-5454
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 45 | Millimeter | |
| Length | 45 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 59 – 86 Degrees Fahrenheit