FDA UDI
In Commercial Distribution
🇺🇸 United States
ViscoStat
DI: 00883205035714
·
Model: 1129
·
ULTRADENT PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ViscoStat
- Primary DI
- 00883205035714
- Version / Model
- 1129
- Catalog Number
- 1129
- Company Name
- ULTRADENT PRODUCTS, INC.
- Labeler DUNS
- 013369913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-08
- Public Version
- 1
- Public Version Date
- 2022-11-16
- Public Version Status
- New
- Public Device Record Key
- 3e104536-47d5-41fe-81df-252a3640f4f7
Device Description
UNIV UD Tissue Management Kit
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| JES | Floss, Dental | Dental | 872.6390 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35861 | Gingival retraction cord, non-medicated | A non-medicated, cotton string used to temporarily hold off the gingiva during abutment preparation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00883205035714 | GS1 |
Customer Contacts
- Phone
- 801-572-4200
- [email protected]