Duns Number:832696038
Device Description: V. Mueller COTTLE CROSSBAR CHISEL- OSTEOTOME BLADE 12MM WIDE OVERALL LENGTH 7-1/4" (18.4CM V. Mueller COTTLE CROSSBAR CHISEL- OSTEOTOME BLADE 12MM WIDE OVERALL LENGTH 7-1/4" (18.4CM)
Catalog Number
RH1414
Brand Name
V. Mueller
Version/Model Number
RH1414
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2021
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
KAN
Product Code Name
CHISEL, NASAL
Public Device Record Key
a1bb550c-8932-4e2c-ac02-c60936ab15d9
Public Version Date
March 07, 2022
Public Version Number
2
DI Record Publish Date
September 10, 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 |