Duns Number:832696038
Device Description: SAUNDERS-PAPARELLA STAPES HOOK, #8, HOOK 0.6MM, ANGLED 90°, MALL 2-3/4" (7CM) SHAFT OVERAL SAUNDERS-PAPARELLA STAPES HOOK, #8, HOOK 0.6MM, ANGLED 90°, MALL 2-3/4" (7CM) SHAFT OVERALL LGTH 6-1/2" (16.5CM)
Catalog Number
AU13770
Brand Name
V. Mueller
Version/Model Number
AU13770
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
JYL
Product Code Name
HOOK, MICROSURGICAL EAR
Public Device Record Key
0eb56c61-73bc-4133-b766-517726192fdf
Public Version Date
September 22, 2020
Public Version Number
3
DI Record Publish Date
July 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 |