FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 06009544050568
·
Model: V2-GC-90772
·
SOUTHERN IMPLANTS (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- N/A
- Primary DI
- 06009544050568
- Version / Model
- V2-GC-90772
- Company Name
- SOUTHERN IMPLANTS (PTY) LTD
- Labeler DUNS
- 636239584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-07-16
- Public Version
- 1
- Public Version Date
- 2025-07-24
- Public Version Status
- New
- Public Device Record Key
- 2284e639-e3c9-4b3d-9739-228b522219ef
Device Description
V2-GC-90772
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65965 | External facial prosthesis attachment frame component | A small noninvasive device intended to be attached to an external facial prosthesis attachment reference device (typically a screw or pin) to function as the attaching frame for the external facial prosthesis (e.g., ear, orbital, nose) [not included]. Typically included are several components that take the form of a screw, rod, bar, or clip to hold/stabilize the in situ prosthesis. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06009544050568 | GS1 |