Duns Number:038000253
Device Description: CATHERINE MCAULEY HOSPITAL 11.5F X 15CM HEMO-CATH® SILICONE CUSTOM TRAY
Catalog Number
-
Brand Name
HEMO-CATH®
Version/Model Number
TRAY #373
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 03, 2017
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"
Yes
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
LFJ
Product Code Name
CATHETER, SUBCLAVIAN
Public Device Record Key
b4b4db87-a255-48c0-bfa3-bf3fc7fe8df6
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
April 29, 2016
Package DI Number
50884908054342
Quantity per Package
5
Contains DI Package
00884908054347
Package Discontinue Date
November 03, 2017
Package Status
Not in Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 31 |
2 | A medical device with a moderate to high risk that requires special controls. | 2560 |