Duns Number:241382683
Device Description: DISPOSABLE HOT BIOPSY FORCEPS, WITHOUT SPIKE, NON-COATED
Catalog Number
DHB-2323AF
Brand Name
Endoch
Version/Model Number
DHB-2323AF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
FCL
Product Code Name
Forceps, Biopsy, Non-Electric
Public Device Record Key
2f3466d8-32d4-466f-8a39-7602c0eba3bf
Public Version Date
June 10, 2019
Public Version Number
1
DI Record Publish Date
June 01, 2019
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 | 325 |
2 | A medical device with a moderate to high risk that requires special controls. | 30 |