Duns Number:038101861
Device Description: Wilson Penile Implantation System™ Retractor Frame, Retractor Stays, & Penile Elevation St Wilson Penile Implantation System™ Retractor Frame, Retractor Stays, & Penile Elevation Strap (Boxed)
Catalog Number
-
Brand Name
TLC® Retractor (Wilson Penile Implantation System™)
Version/Model Number
TLC5042-M
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 21, 2019
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
-
Product Code
GAD
Product Code Name
Retractor
Public Device Record Key
6e8947f5-de1a-40f3-86e7-a162f7f79d76
Public Version Date
May 10, 2021
Public Version Number
5
DI Record Publish Date
September 30, 2018
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 26 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1325 |