Duns Number:627879687
Device Description: The disposable Biopsy Forceps Sheathed are used to obtain mucosal tissue samples during en The disposable Biopsy Forceps Sheathed are used to obtain mucosal tissue samples during endoscopic procedures.
Catalog Number
00711205
Brand Name
NA
Version/Model Number
00711205
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
KNW
Product Code Name
INSTRUMENT, BIOPSY
Public Device Record Key
85b860ed-a310-4eac-add3-8202c5af54b3
Public Version Date
November 10, 2020
Public Version Number
2
DI Record Publish Date
April 01, 2020
Package DI Number
10724995183711
Quantity per Package
5
Contains DI Package
00724995183714
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 |