Duns Number:106135367
Device Description: Black FERRIS SMITH RONGEUR, 7", short cup , 4mm
Catalog Number
52-130-40SMB
Brand Name
Wiggins Medical
Version/Model Number
52-130-40SMB
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
HTX
Product Code Name
Rongeur
Public Device Record Key
21a16ea6-b2e3-481c-bac3-e6ee1709f5f7
Public Version Date
September 05, 2022
Public Version Number
2
DI Record Publish Date
May 22, 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 | 338 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 376 |