Duns Number:544811862
Device Description: ClearPetra Ureteral Access Sheath, 10Fr×55cm
Catalog Number
-
Brand Name
ClearPetra
Version/Model Number
90111055
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
K161110,K161110,K161110
Product Code
FAJ
Product Code Name
Cystoscope And Accessories, Flexible/Rigid
Public Device Record Key
0e9a5c11-b6cf-4a3f-903a-31d92fe71f6c
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 2021
Package DI Number
16944932748054
Quantity per Package
1
Contains DI Package
06944932748057
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |