Duns Number:137354267
Device Description: ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF PROTECTIVE SLEEVE (FOR USE WITH ZIMMER 18 IN. ( ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF PROTECTIVE SLEEVE (FOR USE WITH ZIMMER 18 IN. (46 CM) DISPOSABLE CUFF)
Catalog Number
60-8000-018-00
Brand Name
N/A
Version/Model Number
60-8000-018-00
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
18d535bb-2a40-4a72-9aa3-ad9086beec7f
Public Version Date
November 15, 2021
Public Version Number
1
DI Record Publish Date
November 05, 2021
Package DI Number
00889024381117
Quantity per Package
10
Contains DI Package
00889024377912
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 |