Duns Number:832696038
Device Description: EAR BLADES #71NDK MYRINGOTOMY LANCE TIP
Catalog Number
AU05731-03
Brand Name
V. Mueller
Version/Model Number
AU05731-03
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
Yes
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
EMF
Product Code Name
KNIFE, SURGICAL
Public Device Record Key
6f3e7e55-5a4e-4e12-be32-2f51877d5923
Public Version Date
June 08, 2021
Public Version Number
3
DI Record Publish Date
July 13, 2018
Package DI Number
70885403124442
Quantity per Package
12
Contains DI Package
10885403124440
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| 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 |