Duns Number:081277700
Device Description: Disposable Scoville Bayonet Insulated Bipolar Forceps
Catalog Number
-
Brand Name
Integra® Jarit®
Version/Model Number
286-106
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
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
K831236,K900533,K831236,K900533,K831236,K900533
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
09385861-54fe-4c0a-91d7-d2de533fc31c
Public Version Date
June 08, 2020
Public Version Number
4
DI Record Publish Date
September 13, 2016
Package DI Number
30381780169318
Quantity per Package
5
Contains DI Package
10381780169314
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |