Duns Number:825239189
Device Description: Endoscopic Biopsy Forceps with Needle
Catalog Number
SG-211-615
Brand Name
Biopsy Forceps
Version/Model Number
SG-211-615
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 04, 2019
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
FCL
Product Code Name
Forceps, Biopsy, Non-Electric
Public Device Record Key
4d12a9ef-39ea-4ddb-ae12-083088367073
Public Version Date
November 05, 2019
Public Version Number
2
DI Record Publish Date
May 14, 2018
Package DI Number
10816207020744
Quantity per Package
10
Contains DI Package
00816207020747
Package Discontinue Date
November 04, 2019
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85 |