Duns Number:001406024
Device Description: Sharp Cystotome .55 x 28mm (24G x 1 1/8in)
Catalog Number
585053
Brand Name
Visitec®
Version/Model Number
585053
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
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
HNY
Product Code Name
Cystotome
Public Device Record Key
786c7386-7ca9-4f8b-a2d0-feb2176e99b8
Public Version Date
November 29, 2021
Public Version Number
1
DI Record Publish Date
November 19, 2021
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 | 441 |
2 | A medical device with a moderate to high risk that requires special controls. | 35 |
U | Unclassified | 34 |