Duns Number:100796993
Device Description: Single-Use Digital Flexible Ureteroscope
Catalog Number
-
Brand Name
Aptra
Version/Model Number
BDRD01
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
59a624b9-c631-4563-84e4-a3e45e24cff3
Public Version Date
December 07, 2021
Public Version Number
1
DI Record Publish Date
November 29, 2021
Package DI Number
10850023925036
Quantity per Package
10
Contains DI Package
00850023925039
Package Discontinue Date
-
Package Status
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 |