Duns Number:137354267
Device Description: ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PROTECTIVE SLEEVE AND PLC, SINGLE PORT, SI ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PROTECTIVE SLEEVE AND PLC, SINGLE PORT, SINGLE BLADDER, 42 IN. (107 CM)
Catalog Number
60-7075-157-00
Brand Name
N/A
Version/Model Number
60-7075-157-00
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"
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
KCY
Product Code Name
Tourniquet, Pneumatic
Public Device Record Key
c5defe06-ad56-4629-b616-993886bdb78e
Public Version Date
November 10, 2021
Public Version Number
1
DI Record Publish Date
November 02, 2021
Package DI Number
00889024380943
Quantity per Package
5
Contains DI Package
00889024377479
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1447 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 96 |