Duns Number:713565195
Device Description: These hoods are intended to be used in combination with compatible endoscopes to maintain These hoods are intended to be used in combination with compatible endoscopes to maintain the field of view during an examination of the digestive tract.
Catalog Number
-
Brand Name
FUJIFILM
Version/Model Number
DH-39CZ
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)
Yes
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
687ab9d9-276a-48b7-9f96-cbcc7635f25f
Public Version Date
April 07, 2021
Public Version Number
3
DI Record Publish Date
January 30, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |