FDA UDI
In Commercial Distribution
🇺🇸 United States
Kit accessori monouso TT Transformer
DI: 08055728580015
·
Model: 01
·
TT TOOTH TRANSFORMER SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Kit accessori monouso TT Transformer
- Primary DI
- 08055728580015
- Version / Model
- 01
- Catalog Number
- TT8002
- Company Name
- TT TOOTH TRANSFORMER SRL
- Labeler DUNS
- 437311340
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-29
- Public Version
- 1
- Public Version Date
- 2022-07-07
- Public Version Status
- New
- Public Device Record Key
- 23ddfd7e-67f1-4433-b11a-d93a3d414e53
Device Description
Single use kit to be exclusively used with "TT Transformer" medical device to allow its operation.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEY | Motor, Surgical Instrument, Ac-Powered | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45148 | Dental/maxillofacial surgical procedure kit, non-medicated, single-use | A collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 18055728580012 | GS1 | Box | 16 | In Commercial Distribution | |
| Primary | 08055728580015 | GS1 |