Duns Number:078603710
Device Description: SteriPath Micro, Luer, 5ml
Catalog Number
4005-EN
Brand Name
Steripath Micro
Version/Model Number
4005-EN
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
-
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
7f2a864a-6ba8-4c1f-8042-66b1c4907fca
Public Version Date
April 02, 2021
Public Version Number
1
DI Record Publish Date
March 25, 2021
Package DI Number
10858366007419
Quantity per Package
10
Contains DI Package
00858366007412
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Sales Pack
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 15 |