Duns Number:078352849
Device Description: Serrated Offset double ended Surgical Curette 10S
Catalog Number
Curette Off/Serrated 10S
Brand Name
Tatum Serrated Offset Surgical Curette 10S
Version/Model Number
Serrated Offset Surgical Curette 10S
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
FZS
Product Code Name
Curette, Surgical, General Use
Public Device Record Key
5f68a6a7-8779-40fa-a7b8-927332f1341d
Public Version Date
August 25, 2021
Public Version Number
2
DI Record Publish Date
September 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 | 405 |
2 | A medical device with a moderate to high risk that requires special controls. | 536 |