Duns Number:125111448
Device Description: For AMS 700 Penile Prosthesis CX/LGX and for AMS Spectra Concealable Penile Prosthesis
Catalog Number
-
Brand Name
Rear Tip Extender
Version/Model Number
72404321
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
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
FAE
Product Code Name
Prosthesis, Penile
Public Device Record Key
4591ac4b-cd1f-4da4-be22-26b128291fd2
Public Version Date
June 05, 2019
Public Version Number
5
DI Record Publish Date
August 12, 2016
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 139 |