Duns Number:066839630
Device Description: REPLACEMENT SPRAY TIPS (Tip Alignment Tool with 2 Spray Tips per pouch)
Catalog Number
-
Brand Name
FIBRIJET
Version/Model Number
SA-3659
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
K102563,K102563
Product Code
GCJ
Product Code Name
Laparoscope, General & Plastic Surgery
Public Device Record Key
9b3e9e13-5ec8-4a40-a8c6-fa0892fab4a6
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 25, 2016
Package DI Number
10815634020204
Quantity per Package
10
Contains DI Package
00815634020207
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 |