Duns Number:803401454
Device Description: Rapport constriction ring - Size 8
Catalog Number
-
Brand Name
Rapport Rings
Version/Model Number
SM 2208
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)
Yes
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
dbd413be-a92a-4d7e-83ee-10dfe393c56e
Public Version Date
March 17, 2022
Public Version Number
3
DI Record Publish Date
September 19, 2016
Package DI Number
00384702208033
Quantity per Package
1
Contains DI Package
00384702208019
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |