Power Dental USA
- Primary DI
- D94378303
- Brand
- Power Dental USA
- Company
- Power Dental U.S.A. Inc.
- Model
- 7830-3
- Catalog number
- 7830-3
- Device description
- IMPLANT HEX DRIVER 2.5mm
- Published
- 2021-07-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D94378303 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Dressing/utility forceps, scissors-like, reusable | A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Contacts
| Phone | Email |
|---|
| +1(815)363-8003 | info@mydentalusa.com |
Regulatory Flags
- DUNS number
- 081305064
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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