Duns Number:149818952
Catalog Number
405270
Brand Name
SJM™
Version/Model Number
405270
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
K791129,K791129
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
c0c3a9a2-2d14-4c89-89b3-41a81d2b1626
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
December 03, 2015
Package DI Number
15415067021004
Quantity per Package
10
Contains DI Package
05415067021007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |