Elos Accurate® Prosthetic Screwdriver 34mm 042.0034
GUDID 05712821015969
The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. The product is available in different lengths. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
Surgical screwdriver, reusable| Primary Device ID | 05712821015969 |
| NIH Device Record Key | c5feba3d-ca4e-44f6-a5fe-fe66eb91d315 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elos Accurate® Prosthetic Screwdriver 34mm |
| Version Model Number | 042.0034 |
| Catalog Number | 042.0034 |
| Company DUNS | 306155953 |
| Company Name | Elos Medtech Pinol A/S |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05712821015969 [Primary] |
FDA Product Code
| NDP | Accessories, Implant, Dental, Endosseous |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
[05712821015969]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-08 |
| Device Publish Date | 2025-08-31 |
On-Brand Devices [Elos Accurate® Prosthetic Screwdriver 34mm]
| 05712821006509 | The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. T |
| 05712821015969 | The product consists of the Prosthetic Screwdriver which is manufactured from stainless steel. T |
Trademark Results [Elos Accurate]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ELOS ACCURATE 86837307 5135482 Live/Registered |
Elos Medtech AB 2015-12-02 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.