Duns Number:042961576
Device Description: Bone Fenestration Chisel, Curved
Catalog Number
P99-150-0135
Brand Name
Multi System
Version/Model Number
P99-150-0135
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
HTF
Product Code Name
CURETTE
Public Device Record Key
b8ca9823-4559-4335-a98d-f1a11a3cebbb
Public Version Date
October 25, 2019
Public Version Number
1
DI Record Publish Date
October 17, 2019
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 | 1122 |
2 | A medical device with a moderate to high risk that requires special controls. | 3564 |