Duns Number:340306351
Device Description: Retrofit kit
Catalog Number
-
Brand Name
3D-Modul 8x8 für OP SL/S 2D
Version/Model Number
6593359
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
OAS
Product Code Name
X-Ray, Tomography, Computed, Dental
Public Device Record Key
ada4ed98-3ddd-4116-9e43-7c0d27d2c4d1
Public Version Date
May 17, 2022
Public Version Number
2
DI Record Publish Date
April 15, 2021
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 | 235 |
2 | A medical device with a moderate to high risk that requires special controls. | 326 |