Duns Number:600850213
Device Description: 5 Fr x 10 cm COAX MICRO INTRODUCER, Micro access tip .18 Ni GW with AU tip NON-MARKED, ec 5 Fr x 10 cm COAX MICRO INTRODUCER, Micro access tip .18 Ni GW with AU tip NON-MARKED, echo needle
Catalog Number
-
Brand Name
Typenex Introducer Set
Version/Model Number
MS0636
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
c6a31274-1e1f-4008-940b-b16d8727a5d4
Public Version Date
September 26, 2019
Public Version Number
1
DI Record Publish Date
September 18, 2019
Package DI Number
00812269033046
Quantity per Package
10
Contains DI Package
00812269033039
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| 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 |