Duns Number:801895244
Device Description: M-Style Mushroom Cup Vacuum-Assist Delivery System
Catalog Number
-
Brand Name
Mityvac
Version/Model Number
10007LP
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
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
K890307,K890307,K890307
Product Code
HDB
Product Code Name
Extractor, Vacuum, Fetal
Public Device Record Key
a22357d3-3f13-4344-97c2-18f311f85bd6
Public Version Date
February 21, 2019
Public Version Number
4
DI Record Publish Date
August 30, 2016
Package DI Number
30888937003049
Quantity per Package
24
Contains DI Package
00888937003048
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |