FDA UDI
In Commercial Distribution
🇺🇸 United States
Integrity® TempGrip® Temporary Crown & Bridge Cement
DI: D0026664401
·
Model: 666440
·
DENTSPLY INTERNATIONAL INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Integrity® TempGrip® Temporary Crown & Bridge Cement
- Primary DI
- D0026664401
- Version / Model
- 666440
- Catalog Number
- 666440
- Company Name
- DENTSPLY INTERNATIONAL INC.
- Labeler DUNS
- 083235549
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 4
- Public Version Date
- 2024-04-29
- Public Version Status
- Update
- Public Device Record Key
- 6fff559e-8aa1-472c-b6a2-8c5363be30e0
Device Description
Integrity® TempGrip® Syringe Evaluator Package
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EMA | CEMENT, DENTAL | Dental | 872.3275 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37183 | ESDP endoscope | A dedicated endoscope with a rigid inserted portion intended for the treatment of varicose veins, i.e., endoscopic subfascial dissection of perforating veins (ESDP). It is inserted through an artificial orifice transcutaneously alongside the outside of the perforating vein during the procedure. Anatomical images are transmitted to the user by the device through relayed lens optics. The varicose veins are typically cauterized by using an endotherapy device entered through the endoscope. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D0026664401 | HIBCC |
Customer Contacts
- Phone
- +1(800)532-2855
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 9 | Gram | |
| Device Size Text, specify | 1 Syringe and 9 Mixing Tips |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 8 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight. Keep dry.