Duns Number:605813559
Device Description: Zephyr HDR Accessory - Universal Clamp Bracket for RPD Universal Clamp
Catalog Number
-
Brand Name
Zephyr Patient Positioning and Transfer System
Version/Model Number
ZEP-AUB-70
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 19, 2022
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
K121929
Product Code
FRZ
Product Code Name
Device, Patient Transfer, Powered
Public Device Record Key
5e497576-93da-4d66-ac1d-5ac40e27e519
Public Version Date
September 27, 2022
Public Version Number
1
DI Record Publish Date
September 19, 2022
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 107 |