Duns Number:081277700
Device Description: Jacobson Needle Holder, 9-3/4", Jarit Stardust®, Round Handle, Without Catch, Heavy, Curve Jacobson Needle Holder, 9-3/4", Jarit Stardust®, Round Handle, Without Catch, Heavy, Curved
Catalog Number
278-135NL
Brand Name
Integra® Jarit®
Version/Model Number
278135NL
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
-
Product Code
DWS
Product Code Name
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Public Device Record Key
bf66a86f-c411-49c6-86ee-d7b3705989d2
Public Version Date
November 03, 2021
Public Version Number
5
DI Record Publish Date
March 22, 2018
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 |