Duns Number:057027601
Device Description: Play With Me - Lick It - Vibrating Double Strap Cock Ring - PurplePart Number: BL-61911Mat Play With Me - Lick It - Vibrating Double Strap Cock Ring - PurplePart Number: BL-61911Material Type: TPE
Catalog Number
BL-61911
Brand Name
PLAY WITH ME
Version/Model Number
Play With Me - Lick It - Vibrating Double Strap Cock Ring - Purple
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LKY
Product Code Name
Device, External Penile Rigidity
Public Device Record Key
c0e1f546-f5f4-4f85-962d-b60e6b02c9bf
Public Version Date
November 06, 2019
Public Version Number
1
DI Record Publish Date
October 29, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 105 |