Duns Number:103169095
Device Description: Adapter Set for flexible endoscope, includes 1 – BIOPSY PORT PLUG, 1 – SUCTION PORT PLUG, Adapter Set for flexible endoscope, includes 1 – BIOPSY PORT PLUG, 1 – SUCTION PORT PLUG, 1 – AIR/WATER PORT ADAPTOR, 1 – LL-MTF CONNECTOR, & 1 – TS- TUBING SOFT .25 ID X .375 OD X 2.5 LENGTH, Single Use - 1 Set. 120 Sets per Case
Catalog Number
-
Brand Name
Adapter Set for flexible endoscope
Version/Model Number
ASF2
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
a59600a9-eb20-4c2a-b565-6c032a80a834
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
September 24, 2020
Package DI Number
10843356102243
Quantity per Package
120
Contains DI Package
00843356102246
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 |