Duns Number:080593067
Device Description: ONSET FEMORAL INTRODUCER KIT 6 Fr
Catalog Number
M95F61135J
Brand Name
MEDADV
Version/Model Number
M95F61135J
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"
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
K123475,K123475
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
c36e5670-40b2-4539-a9ec-233ff44874a6
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
April 09, 2018
Package DI Number
10819667020743
Quantity per Package
5
Contains DI Package
00819667020746
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 40 |