Duns Number:291993439
Catalog Number
360712
Brand Name
JAZZ System
Version/Model Number
JAZZ Claw – Hook Left
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
K191217
Product Code
OWI
Product Code Name
Bone Fixation Cerclage, Sublaminar
Public Device Record Key
2118ec70-d902-49ee-a6e8-81ec5437c166
Public Version Date
September 22, 2020
Public Version Number
1
DI Record Publish Date
September 14, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 236 |
2 | A medical device with a moderate to high risk that requires special controls. | 828 |