Duns Number:508701849
Device Description: The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic pu The Lelo Hex Natural Rubber Latex Condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).
Catalog Number
-
Brand Name
LELO HEX RE-ENGINEERED LATEX CONDOM ORIGINAL - 6 PACK
Version/Model Number
3453
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
HIS
Product Code Name
Condom
Public Device Record Key
c1587153-1c6d-4e17-a45c-04fbeb9a0621
Public Version Date
June 06, 2022
Public Version Number
1
DI Record Publish Date
May 27, 2022
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. | 20 |