Duns Number:080506581
Device Description: ACETABULAR EXTR CHISEL 13in
Catalog Number
602014000
Brand Name
NA
Version/Model Number
6020-14-000
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HWB
Product Code Name
EXTRACTOR
Public Device Record Key
d2641a79-caf9-49e9-a6d8-e1384cbf10ed
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
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 | 5254 |
2 | A medical device with a moderate to high risk that requires special controls. | 4003 |
3 | A medical device with high risk that requires premarket approval | 908 |