Duns Number:600850213
Device Description: 7F x 10cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Man 7F x 10cm Venous Coaxial Introducer, tipped for .018 Micro Access, .018 x 40cm NiTi/AU Mandrel Guidewire 7.0 coil with St. Tip, 21Ga x 7cm Introducer Needle - Echogenic
Catalog Number
-
Brand Name
Typenex Introducer Set
Version/Model Number
MS2112
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
OFL
Product Code Name
Percutaneous Sheath Introducer Kit
Public Device Record Key
25d311e9-2faf-468a-9abc-764a5427631c
Public Version Date
August 19, 2021
Public Version Number
1
DI Record Publish Date
August 11, 2021
Package DI Number
10810050853801
Quantity per Package
10
Contains DI Package
00810050853804
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 | 39 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |