Duns Number:030650113
Device Description: GIJaw Single-Use Biopsy Forceps with Needle
Catalog Number
1190-01
Brand Name
GIJaw
Version/Model Number
1190-01
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
FCL
Product Code Name
Forceps, Biopsy, Non-Electric
Public Device Record Key
897f2ee5-876a-451f-bd1a-3ad6f9aae662
Public Version Date
March 22, 2019
Public Version Number
2
DI Record Publish Date
August 01, 2018
Package DI Number
10816734021627
Quantity per Package
10
Contains DI Package
00816734021620
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 | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |