FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Vintage MP/Vintage Art
DI: E2359627TK0
·
Model: 001
·
SHOFU DENTAL CORPORATION
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vintage MP/Vintage Art
- Primary DI
- E2359627TK0
- Version / Model
- 001
- Catalog Number
- 9627TK
- Company Name
- SHOFU DENTAL CORPORATION
- Labeler DUNS
- 054618202
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-27
- Public Version
- 2
- Public Version Date
- 2019-12-11
- Public Version Status
- Update
- Public Device Record Key
- 77e1afac-ee86-439c-8c02-f6b6f27da65d
- Distribution End Date
- 2019-12-10
Device Description
One Shot Vintage MP Trial Kit. Contains DI's: E23596270, E23592600, E23592610, E23592680, E23592720, E23592760, E23565130, E23565140, E23565170, E23565260, E23565270, E23565280, E23565290
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44727 | Dental porcelain/ceramic restoration kit | A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E2359627TK0 | HIBCC |
Customer Contacts
- Phone
- 760-566-3528
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 1 – 30 Degrees Celsius