Duns Number:344007369
Device Description: The AWC is an additional working channel for flexible endoscopes • external channel for The AWC is an additional working channel for flexible endoscopes • external channel for insertion of instruments or flushing and suction • it consists of: distal attachment (cap) shaft adaptor for fixation at the endoscope handle sleeve valve and Luer Lock connection tapes for fixation • for gastroscopes with insertion length of 103 - 110 cm
Catalog Number
200.57.01
Brand Name
AWC
Version/Model Number
122 cm
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"
Yes
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
-
Product Code
FZX
Product Code Name
Guide, Surgical, Instrument
Public Device Record Key
9b50658a-50be-4ecc-b542-43d1a7da4430
Public Version Date
October 31, 2019
Public Version Number
4
DI Record Publish Date
May 28, 2018
Package DI Number
04260206310945
Quantity per Package
2
Contains DI Package
04260206310952
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Folding box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |