Duns Number:081277700
Device Description: Debakey Forceps, 7-3/4", Cardio-Grip, Flat Handle, Atraumatic, Straight, 1.5mm Wide, Tita Debakey Forceps, 7-3/4", Cardio-Grip, Flat Handle, Atraumatic, Straight, 1.5mm Wide, Titanium
Catalog Number
320-081TI
Brand Name
Integra® Jarit®
Version/Model Number
320081TI
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
66d23550-2b0a-4542-a943-f9b86f0de447
Public Version Date
November 05, 2021
Public Version Number
7
DI Record Publish Date
October 31, 2017
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 |