Duns Number:627879687
Device Description: The Reveal distal attachment cap is attached to the distal end of the endoscope to facilit The Reveal distal attachment cap is attached to the distal end of the endoscope to facilitate endoscopic therapy and is intended for gastrointestinal mucosal resection (endoscopic mucosal resection) and keeping the suitable depth of endoscope's view field.
Catalog Number
00711774
Brand Name
Reveal
Version/Model Number
00711774
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
OCX
Product Code Name
endoscopic irrigation/suction system
Public Device Record Key
b47ff6eb-2172-4d60-9ce2-f14689dbb131
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
April 01, 2020
Package DI Number
10724995184770
Quantity per Package
10
Contains DI Package
00724995184773
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |