Duns Number:266062561
Device Description: DISCOVERY IGS 740 002
Catalog Number
-
Brand Name
DISCOVERY
Version/Model Number
IGS 740 002
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133278
Product Code
JAA
Product Code Name
System, x-ray, fluoroscopic, image-intensified
Public Device Record Key
b5e17e6a-3beb-44c0-88d8-0b35e5677845
Public Version Date
February 01, 2022
Public Version Number
4
DI Record Publish Date
August 01, 2016
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |
| 3 | A medical device with high risk that requires premarket approval | 5 |