Duns Number:071595540
Device Description: FS:RT:D,GRAB,36 INCH W.B.R.
Catalog Number
590319
Brand Name
NA
Version/Model Number
590319
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 04, 2021
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
IKD
Product Code Name
CABLE, ELECTRODE
Public Device Record Key
ed7b0dcf-d15d-4155-8611-cb4cbfa2ed7d
Public Version Date
April 05, 2021
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405003073
Quantity per Package
10
Contains DI Package
10653405003076
Package Discontinue Date
April 04, 2021
Package Status
Not in Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |