Duns Number:832696038
Device Description: LEKSELL RONGUER FORCEPS DOUBLE-ACTION, FULLY CURVED JAWS 5 X 16MM WIDE OVERALL LENGTH 8-1/ LEKSELL RONGUER FORCEPS DOUBLE-ACTION, FULLY CURVED JAWS 5 X 16MM WIDE OVERALL LENGTH 8-1/2" (21.6CM)
Catalog Number
NL631-001
Brand Name
V. Mueller
Version/Model Number
NL631-001
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
3d9bc8b9-e4d7-4379-b613-7b057e6dc9bd
Public Version Date
February 11, 2020
Public Version Number
4
DI Record Publish Date
September 23, 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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |