Duns Number:488133448
Catalog Number
75.12.92
Brand Name
N/A
Version/Model Number
75.12.92
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
-
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
FZO
Product Code Name
CHISEL, SURGICAL, MANUAL
Public Device Record Key
d7e21ab9-e9c2-4805-a18e-316336b6af49
Public Version Date
April 08, 2022
Public Version Number
2
DI Record Publish Date
June 30, 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 | 338 |
2 | A medical device with a moderate to high risk that requires special controls. | 3101 |