Duns Number:100439103
Device Description: Zimmer Tourniquet 18 in.
Catalog Number
-
Brand Name
Zimmer Tourniquet
Version/Model Number
RM-60707500300
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
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
adecfe42-ccd1-471a-8222-d3d3a2cbc486
Public Version Date
August 02, 2019
Public Version Number
3
DI Record Publish Date
June 16, 2017
Package DI Number
10816317023314
Quantity per Package
10
Contains DI Package
00816317023317
Package Discontinue Date
-
Package Status
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 | 68 |
2 | A medical device with a moderate to high risk that requires special controls. | 95 |