FDA UDI
In Commercial Distribution
🇺🇸 United States
DiamoDent
DI: D907T54920
·
Model: N/A
·
DIAMODENT INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DiamoDent
- Primary DI
- D907T54920
- Version / Model
- N/A
- Catalog Number
- T5492
- Company Name
- DIAMODENT INC
- Labeler DUNS
- 013827410
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-08
- Public Version
- 1
- Public Version Date
- 2020-07-16
- Public Version Status
- New
- Public Device Record Key
- d349722d-f1cb-4fef-bbac-3c7e7908c129
Device Description
Square Adapter for Straumann Torque Wrench
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
- No
- PM Exempt
- Yes
- 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
- Yes
- Sterilization Methods
- Dry Heat Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZN | Instruments, Dental Hand | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64373 | Dental torque wrench adaptor | A component of a dental torque wrench (typically ratchet type) intended to enable connection of the main body of the wrench to a specific endpiece(s). It is intended to be used during an invasive surgical procedure and is dedicated to dental use only. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D907T54920 | HIBCC |