Duns Number:306155953
Device Description: The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured The product consists of the Elos Accurate® Analog for Printed Models (Analog) manufactured in the biocompatible material titanium alloy grade 5 ELI (TiAl6V4 ELI).
Catalog Number
N/a
Brand Name
Elos Accurate® Analog for Printed Models
Version/Model Number
PMA-ZSV35-50
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
Yes
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
90147aa1-1b14-4c71-8be8-22c925b92d7f
Public Version Date
March 19, 2020
Public Version Number
1
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 |