FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Drill Extender
DI: 05712821001078
·
Model: c7650
·
Elos Medtech Pinol A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Drill Extender
- Primary DI
- 05712821001078
- Version / Model
- c7650
- Company Name
- Elos Medtech Pinol A/S
- Labeler DUNS
- 306155953
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-11
- Public Version
- 3
- Public Version Date
- 2024-12-04
- Public Version Status
- Update
- Public Device Record Key
- 3e9d74e8-602e-46a6-943e-30e31f836c49
- Distribution End Date
- 2022-11-20
Device Description
The Elos Drill Extender is for extending tools with ISO 1797 connections. The device is made of stainless steel. The Elos Drill Extender design, finish and quality makes the tool well suited for extending a drill or dental tool and to placement and adjustment of implants, abutments and prosthetic screws. The Elos Drill Extender is easy to prepare for cleaning, disinfection and sterilization.
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
- 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 |
|---|---|---|---|---|
| NDP | Accessories, Implant, Dental, Endosseous | Dental | 872.3980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45320 | Dental drill bit extension | A device intended to be attached to the shaft of a normal dental drill bit in order to lengthen it, providing greater accessibility and/or drilling capacity during a dental procedure. It is typically made of a high-grade metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05712821001078 | GS1 |