FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Virtual
DI: D707607909AN0
·
Model: 607909AN
·
IVOCLAR VIVADENT, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Virtual
- Primary DI
- D707607909AN0
- Version / Model
- 607909AN
- Catalog Number
- 607909AN
- Company Name
- IVOCLAR VIVADENT, INC.
- Labeler DUNS
- 176935203
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2017-04-07
- Public Version
- 3
- Public Version Date
- 2018-11-16
- Public Version Status
- Update
- Public Device Record Key
- b740a04b-5570-4197-ae13-7d435d0d00fd
- Distribution End Date
- 2018-11-12
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ELW | MATERIAL, IMPRESSION | Dental | 872.3660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35866 | Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D707607909AN0 | HIBCC | ||||
| Unit of Use | D707607909AN1 | HIBCC |