Duns Number:131489882
Device Description: GLIDEACCESS System Percutaneous Sheath Introducer Kit
Catalog Number
RSM08
Brand Name
GLIDEACCESS
Version/Model Number
RSM08
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
-
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
befa28f2-8237-4b3d-96ca-9130e664f23a
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
30389701007954
Quantity per Package
10
Contains DI Package
00389701007953
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 142 |
| 3 | A medical device with high risk that requires premarket approval | 4 |