Duns Number:713565195
Device Description: These hoods are intended to be used in combination with compatibleendoscopes to maintain t These hoods are intended to be used in combination with compatibleendoscopes to maintain the field of view during endoscopic proceduressuch as mucosal resection.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
DH-29CR
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
FDF
Product Code Name
Colonoscope and accessories, flexible/rigid
Public Device Record Key
cc42c3be-00c7-4b41-95ab-ddf60f8f62df
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
July 21, 2017
Package DI Number
14547410331667
Quantity per Package
5
Contains DI Package
04547410331660
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |