Duns Number:045738761
Device Description: Waist/Leg Strap Extender
Catalog Number
9029
Brand Name
RigiScan
Version/Model Number
9029
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LIL
Product Code Name
Monitor, Penile Tumescence
Public Device Record Key
2cd4fdff-e146-4390-8f8f-ef21e99fa74b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 01, 2017
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 |
---|---|---|
U | Unclassified | 13 |