Duns Number:100796993
Device Description: Single-Use Digital Flexible Ureteroscope
Catalog Number
-
Brand Name
Aptra
Version/Model Number
BDSD01
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
K181977,K181977
Product Code
FGB
Product Code Name
Ureteroscope And Accessories, Flexible/Rigid
Public Device Record Key
364f389a-4f41-4e9b-ae31-3482dbcc62c0
Public Version Date
December 02, 2021
Public Version Number
1
DI Record Publish Date
November 24, 2021
Package DI Number
10850023925029
Quantity per Package
10
Contains DI Package
00850023925022
Package Discontinue Date
November 24, 2021
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |