FDA UDI
In Commercial Distribution
🇺🇸 United States
INVASIVE ACCESSORIES AND INSTRUMENTS
DI: 08059224111353
·
Model: ESTRATTORE IMP. DRIVE CM (NEODENT)
·
RHEIN 83 SRL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- INVASIVE ACCESSORIES AND INSTRUMENTS
- Primary DI
- 08059224111353
- Version / Model
- ESTRATTORE IMP. DRIVE CM (NEODENT)
- Catalog Number
- 680NCM
- Company Name
- RHEIN 83 SRL
- Labeler DUNS
- 439240722
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-07-08
- Public Version
- 2
- Public Version Date
- 2024-06-19
- Public Version Status
- Update
- Public Device Record Key
- 9ad15e3b-58fb-4985-a55f-d4531903d818
Device Description
Burs used to remove broken screws from the internal thread of the implant.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DZA | Drill, Dental, Intraoral | Dental | 872.4130 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64627 | Dental implant holding endpiece, reusable | A device intended to hold a dental implant (e.g., orthodontic implant screw) at its distal end during the application of the implant to the patient’s oral cavity. It is typically a small metal shaft with an opening at its distal end designed to be mounted onto the distal end of a manual screwdriver or power tool whereby rotation is applied to introduce the implant into a surgical cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08059224111353 | GS1 |