Duns Number:066839630
Device Description: 360° ENDOSCOPIC APPLICATOR WITH TETHER, 5MM x 40CM, 1:1 RATIO (US Indication)
Catalog Number
-
Brand Name
FIBRIJET
Version/Model Number
SA-3768
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 01, 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
K122526,K122526,K122526
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
34e65b2f-2491-47c4-84ad-9934979b0870
Public Version Date
March 02, 2021
Public Version Number
4
DI Record Publish Date
January 13, 2017
Package DI Number
20815634020508
Quantity per Package
1
Contains DI Package
10815634020501
Package Discontinue Date
March 01, 2021
Package Status
Not in Commercial Distribution
Package Type
SHIP BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 34 |