Duns Number:177939027
Device Description: 18" x 4.0" Zimmer ATS Cuff - Red - Single Bladder - Dual Port - QC
Catalog Number
-
Brand Name
Zimmer
Version/Model Number
60-7070-103
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCY
Product Code Name
Tourniquet, Pneumatic
Public Device Record Key
427db10b-5c69-4caa-947c-9bc9204c709c
Public Version Date
March 19, 2021
Public Version Number
3
DI Record Publish Date
January 15, 2018
Package DI Number
50817357021269
Quantity per Package
2
Contains DI Package
30817357021265
Package Discontinue Date
March 19, 2021
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |