Duns Number:100439103
Device Description: Zimmer Tourniquet 42 in. SPSB 60-7075-107-00
Catalog Number
-
Brand Name
Zimmer Tourniquet
Version/Model Number
RM-60-7075-107-00
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"
-
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
75187e8c-7a41-4eb5-9163-38ddd453958d
Public Version Date
May 10, 2021
Public Version Number
4
DI Record Publish Date
June 27, 2019
Package DI Number
10816317023697
Quantity per Package
10
Contains DI Package
00816317023690
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 |