Duns Number:086618626
Device Description: BRUNS CURETTE 6 1/4"HOLL.ROUND #000
Catalog Number
OM 49-0120
Brand Name
ORTHOMED
Version/Model Number
OM 49-0120
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
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
72f7389c-ee63-4cfc-857c-817713083d89
Public Version Date
June 10, 2021
Public Version Number
1
DI Record Publish Date
June 02, 2021
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 | 938 |
2 | A medical device with a moderate to high risk that requires special controls. | 155 |