Duns Number:627879687
Device Description: The Biopsy Forceps Hot Enteroscope is a disposable biopsy forceps used to obtain mucosal t The Biopsy Forceps Hot Enteroscope is a disposable biopsy forceps used to obtain mucosal tissue samples during endoscopic procedures.
Catalog Number
00711295
Brand Name
NA
Version/Model Number
00711295
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 08, 2021
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
KGE
Product Code Name
FORCEPS, BIOPSY, ELECTRIC
Public Device Record Key
649fc699-3df7-4ef2-8603-287b106a3f81
Public Version Date
December 08, 2021
Public Version Number
4
DI Record Publish Date
April 01, 2020
Package DI Number
10724995183766
Quantity per Package
5
Contains DI Package
00724995183769
Package Discontinue Date
December 08, 2021
Package Status
Not 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 |