Duns Number:106135367
Device Description: Black Ejector Kerrison Rongeur, 40° up, standard footplate, 2mm, 12"
Catalog Number
-
Brand Name
Wiggins Medical
Version/Model Number
52-168-02EB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 04, 2022
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
K200383
Product Code
HAE
Product Code Name
Rongeur, Manual
Public Device Record Key
9ef6eb31-18f2-4ea3-a744-8db800bd384b
Public Version Date
September 12, 2022
Public Version Number
3
DI Record Publish Date
October 01, 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 |