Duns Number:063519193
Device Description: Ziehm Imaging C-Arm Equipment Covers Clear Polyethylene Sterile Fits Ziehm Solo FD and Zie Ziehm Imaging C-Arm Equipment Covers Clear Polyethylene Sterile Fits Ziehm Solo FD and Ziehm Vision FD 12 per Case
Catalog Number
-
Brand Name
Ziehm Imaging
Version/Model Number
33195
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 22, 2022
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"
Yes
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
KKX
Product Code Name
Drape, Surgical
Public Device Record Key
3c393e01-7350-4a4b-a359-c210cbd5faba
Public Version Date
September 23, 2022
Public Version Number
3
DI Record Publish Date
February 24, 2017
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. | 2255 |