Duns Number:140727624
Device Description: 7F OneStic Micro-Access Introducer
Catalog Number
497847
Brand Name
OneStic Micro-Access Introducer
Version/Model Number
497847
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
K780126,K780126,K780126
Product Code
DRE
Product Code Name
Dilator, Vessel, For Percutaneous Catheterization
Public Device Record Key
a3b8cd0a-df78-483e-b624-a50b02081a9e
Public Version Date
August 13, 2019
Public Version Number
1
DI Record Publish Date
August 05, 2019
Package DI Number
10886333224668
Quantity per Package
10
Contains DI Package
00886333224661
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 347 |
2 | A medical device with a moderate to high risk that requires special controls. | 1205 |