FDA UDI
In Commercial Distribution
🇺🇸 United States
Elos Accurate® Prosthetic Screwdriver 34mm
DI: 05712821015969
·
Model: 042.0034
·
Elos Medtech Pinol A/S
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Elos Accurate® Prosthetic Screwdriver 34mm
- Primary DI
- 05712821015969
- Version / Model
- 042.0034
- Catalog Number
- 042.0034
- Company Name
- Elos Medtech Pinol A/S
- Labeler DUNS
- 306155953
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-31
- Public Version
- 1
- Public Version Date
- 2025-09-08
- Public Version Status
- New
- Public Device Record Key
- c5feba3d-ca4e-44f6-a5fe-fe66eb91d315
Device Description
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.
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 |
|---|---|---|---|---|
| 33968 | Surgical screwdriver, reusable | A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05712821015969 | GS1 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius