Duns Number:832696038
Device Description: AUSTIN RIGHT ANGLED ELEVATOR BLADE 2MM WIDE, ANGLED 90DEG WORKING LENGTH 2-3/4" (7CM) OVER AUSTIN RIGHT ANGLED ELEVATOR BLADE 2MM WIDE, ANGLED 90DEG WORKING LENGTH 2-3/4" (7CM) OVERALL LENGTH 6-1/4" (16CM)
Catalog Number
AU21004
Brand Name
V. Mueller
Version/Model Number
AU21004
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
KAD
Product Code Name
ELEVATOR, ENT
Public Device Record Key
1698a018-12e3-42c6-821f-f70a0324f02a
Public Version Date
April 27, 2020
Public Version Number
3
DI Record Publish Date
August 02, 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 |