Duns Number:832696038
Device Description: GORNEY SUCTION ELEVATOR 19CM (7-1/2"), ROUND END
Catalog Number
88-3850
Brand Name
V. Mueller
Version/Model Number
88-3850
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 23, 2019
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
KAE
Product Code Name
FORCEPS, ENT
Public Device Record Key
47d6e4bb-ced0-4e70-b9bf-de45dee0c48e
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 |