Duns Number:015272206
Device Description: Wilde IVD rongeur, 8", working length 140mm, straight, 6.0mm x 13.0mm fenestrated cup jaws Wilde IVD rongeur, 8", working length 140mm, straight, 6.0mm x 13.0mm fenestrated cup jaws, ring handle
Catalog Number
75-952
Brand Name
Ambler Surgical
Version/Model Number
75-952
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
K081651
Product Code
HAE
Product Code Name
RONGEUR, MANUAL
Public Device Record Key
03011c39-09f6-4aba-9bde-84d66d3173cc
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
September 29, 2016
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 | 14984 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3118 |