Duns Number:100439103
Device Description: Zimmer Tourniquet 42 in. DPSB 60707000700
Catalog Number
-
Brand Name
Zimmer Tourniquet
Version/Model Number
RM-60707000700
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"
-
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
3094e078-4438-4024-86dc-1f7e3ba96437
Public Version Date
August 02, 2019
Public Version Number
4
DI Record Publish Date
March 31, 2017
Package DI Number
10816317023116
Quantity per Package
10
Contains DI Package
00816317023119
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 |