Duns Number:627879687
Device Description: The Histoguide wire guided forceps are disposable flexible wire-guided forceps used to sam The Histoguide wire guided forceps are disposable flexible wire-guided forceps used to sample tissue within the gastrointestinal tract.
Catalog Number
00711660
Brand Name
Histoguide wire guided forceps
Version/Model Number
00711660
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 31, 2020
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
PTS
Product Code Name
Endoscopic grasping/cutting instrument, non-powered, exempt
Public Device Record Key
8d8ed056-bb02-4d4d-89a1-a8bcb1e6d4ef
Public Version Date
March 31, 2020
Public Version Number
4
DI Record Publish Date
July 30, 2018
Package DI Number
10816765014292
Quantity per Package
5
Contains DI Package
00816765014295
Package Discontinue Date
March 31, 2020
Package Status
Not 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 | 51 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 902 |