Duns Number:196548481
Device Description: Integrated Tubing and Bipolar Cord Set, Disposable, Unitized Plug
Catalog Number
6790-100-002
Brand Name
N/A
Version/Model Number
6790-100-002
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
-
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
0e085030-8225-4fc9-b657-c7aa159c9077
Public Version Date
April 23, 2019
Public Version Number
5
DI Record Publish Date
January 03, 2017
Package DI Number
37613327304252
Quantity per Package
10
Contains DI Package
07613327304251
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 2188 |
2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
U | Unclassified | 60 |