Duns Number:106135367
Device Description: Black Micro-Cushing IVD Pituitary Rongeur, 1mm up, 9"
Catalog Number
52-111-10B
Brand Name
Wiggins Medical
Version/Model Number
52-111-10B
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
918500bf-9499-48fa-84a6-088c18d599ab
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 |