Duns Number:832696038
Device Description: HAJEK-BALLENGER SEPTUM ELEVATOR & DISSECTOR DOUBLE-ENDED,SHARP & BLUNT BLD OVERALL LENGTH HAJEK-BALLENGER SEPTUM ELEVATOR & DISSECTOR DOUBLE-ENDED,SHARP & BLUNT BLD OVERALL LENGTH 7-1/2"(19.1CM)
Catalog Number
RH790
Brand Name
V. Mueller
Version/Model Number
RH790
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
955b7644-3070-463e-b9c1-f3734966fd07
Public Version Date
July 12, 2019
Public Version Number
2
DI Record Publish Date
September 14, 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 |