Duns Number:961027315
Device Description: 12FR FRAZIER SUCTION HANDLE
Catalog Number
K73
Brand Name
CARDINAL HEALTH
Version/Model Number
K73
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
GCX
Product Code Name
APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
Public Device Record Key
e5268212-fac8-4116-81d5-0c7c00117baa
Public Version Date
April 20, 2020
Public Version Number
5
DI Record Publish Date
August 26, 2016
Package DI Number
50630140041073
Quantity per Package
50
Contains DI Package
20630140041072
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 | 101686 |
2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
3 | A medical device with high risk that requires premarket approval | 8 |
U | Unclassified | 40 |