Duns Number:806136177
Device Description: GC ECOPAC 8F .088 AL 1 100CM
Catalog Number
588843E
Brand Name
VISTA BRITE TIP
Version/Model Number
588843E
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
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
14675291-0ec3-4d6a-a47d-41610865921a
Public Version Date
September 14, 2022
Public Version Number
9
DI Record Publish Date
August 01, 2016
Package DI Number
20705032017487
Quantity per Package
5
Contains DI Package
10705032017480
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2567 |
| 3 | A medical device with high risk that requires premarket approval | 204 |