Duns Number:094651270
Device Description: OBSTETRICAL VACUUM DELIVERY KIT, 65 mm Tender Touch Ultra Cup, Tube, & Fluid Trap
Catalog Number
303TTL
Brand Name
CMI
Version/Model Number
Tender Touch Cup
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K910788,K910788
Product Code
HIS
Product Code Name
Condom
Public Device Record Key
0744236e-06d8-4eb3-8901-fbd390137ce6
Public Version Date
December 18, 2019
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H671303TTL1
Quantity per Package
10
Contains DI Package
H671303TTL0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |