Duns Number:079398589
Device Description: Curette Right angled
Catalog Number
12-9019
Brand Name
Intervertebral Body Fusion Device
Version/Model Number
12-9019
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
HTF
Product Code Name
Curette
Public Device Record Key
87e98278-7d1b-4107-a5b8-c8b0e46f8ab8
Public Version Date
April 05, 2019
Public Version Number
1
DI Record Publish Date
March 28, 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 | 1423 |
2 | A medical device with a moderate to high risk that requires special controls. | 4960 |
U | Unclassified | 26 |