Duns Number:081277700
Device Description: Stoney Heparin Injector
Catalog Number
310-379
Brand Name
Integra® Jarit®
Version/Model Number
310379
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"
-
For Single-Use
-
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
K131446
Product Code
DQR
Product Code Name
CANNULA, CATHETER
Public Device Record Key
e8d25422-4621-4e1e-9a4e-7fd7f5c6b2d9
Public Version Date
December 03, 2021
Public Version Number
8
DI Record Publish Date
August 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 15051 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4286 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 3 |