Duns Number:801895244
Device Description: Mystic® II MitySoft® Bell Cup Vacuum-Assist Delivery System
Catalog Number
-
Brand Name
Mystic
Version/Model Number
10058
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
K011532,K011532,K011532
Product Code
HDB
Product Code Name
Extractor, Vacuum, Fetal
Public Device Record Key
dc0a7b1c-5a90-4317-9f2e-ce6e048dd8e3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 16, 2016
Package DI Number
20888937003110
Quantity per Package
12
Contains DI Package
00888937003116
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 |