Duns Number:832696038
Device Description: FRONTAL OSTRUM SEEKER DOUBLE ENDED, CURVED RIGHT ANGLE HOOK ON ONE END OVERALL LENGTH 8-1/ FRONTAL OSTRUM SEEKER DOUBLE ENDED, CURVED RIGHT ANGLE HOOK ON ONE END OVERALL LENGTH 8-1/4" (21 CM)
Catalog Number
RH550-252
Brand Name
V. Mueller
Version/Model Number
RH550-252
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
5ad6a68a-c38b-47d1-a431-f31c54ec45e3
Public Version Date
November 12, 2020
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 |