Duns Number:801895244
Device Description: Mityvac Vacuum-Assist Delivery System Super M-Style® Mushroom Cup Vacuum-Assist Delivery S Mityvac Vacuum-Assist Delivery System Super M-Style® Mushroom Cup Vacuum-Assist Delivery System
Catalog Number
-
Brand Name
Mityvac
Version/Model Number
10008
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"
Yes
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
K943938,K943938,K943938
Product Code
HDB
Product Code Name
Extractor, Vacuum, Fetal
Public Device Record Key
598a242e-7941-494d-bf4f-8851baf80bf8
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
30888937003056
Quantity per Package
2
Contains DI Package
20888937003059
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |