Duns Number:832696038
Device Description: CLEANACCESS KERRISON RONGEUR T-COAT MICRO HANDLE 40DEG UP, 6MM BITE, 10MM OPENING SHAFT LE CLEANACCESS KERRISON RONGEUR T-COAT MICRO HANDLE 40DEG UP, 6MM BITE, 10MM OPENING SHAFT LENGTH 10" (25.4CM)
Catalog Number
NL4291-06T
Brand Name
V. Mueller
Version/Model Number
NL4291-06T
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
HAE
Product Code Name
RONGEUR, MANUAL
Public Device Record Key
0f3cc7c1-790d-4824-b0c4-779ba0392762
Public Version Date
May 18, 2021
Public Version Number
3
DI Record Publish Date
August 13, 2018
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 |