Duns Number:306155953
Device Description: The product consists of the Prosthetic Screwdriver which is manufactured from stainless st 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.
Catalog Number
PS-AH18-1
Brand Name
Elos Accurate® Prosthetic Screwdriver 18mm
Version/Model Number
PS-AH18-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NDP
Product Code Name
Accessories, Implant, Dental, Endosseous
Public Device Record Key
d39a8aaf-6d5b-4f2e-82cf-b5752a8f2f30
Public Version Date
July 29, 2022
Public Version Number
2
DI Record Publish Date
March 11, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |