Duns Number:066839630
Device Description: GAS-ASSISTED SPRAY SET ENDOSCOPIC APP. 5MM 30 CM, 1:1 RATIO
Catalog Number
-
Brand Name
FIBRIJET
Version/Model Number
SA-3654
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
K042834,K042834,K042834
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
da18fb3c-9fd2-479e-a65e-13983acbaf86
Public Version Date
March 02, 2021
Public Version Number
4
DI Record Publish Date
September 25, 2016
Package DI Number
10815634020075
Quantity per Package
5
Contains DI Package
00815634020078
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
SHELF 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 |