Duns Number:103169095
Device Description: "Adapter Set for flexible endoscopes, includes 1 – Suction Tube Adapter,1 – Suction Port C "Adapter Set for flexible endoscopes, includes 1 – Suction Tube Adapter,1 – Suction Port Cap, 1 – Air/Water Port Adapter, 1 – Biopsy Port Cap, and1 – Auxiliary Water Jet Port Adapter. 700 series. Single Use. 5 pc set - 1 set. 100 Sets per Case
Catalog Number
-
Brand Name
Adapter Set for flexible endoscope, 700 Series.
Version/Model Number
ASF7
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JRJ
Product Code Name
Unit, Drying
Public Device Record Key
582c1553-4471-4a8b-950b-8deaaac7e24f
Public Version Date
July 08, 2022
Public Version Number
1
DI Record Publish Date
June 30, 2022
Package DI Number
10843356101918
Quantity per Package
100
Contains DI Package
00843356101911
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 146 |