Duns Number:690543319
Device Description: GLIDESHEATH SLENDER Hydrophobic Coated Introducer Sheath
Catalog Number
RM*RS5F16PA
Brand Name
GLIDESHEATH SLENDER
Version/Model Number
RM*RS5F16PA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2018
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
9398ed7e-f26a-4f58-bfbf-2641f4491edc
Public Version Date
June 07, 2019
Public Version Number
4
DI Record Publish Date
September 09, 2016
Package DI Number
54987350722787
Quantity per Package
4
Contains DI Package
34987350722783
Package Discontinue Date
July 31, 2018
Package Status
Not 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 | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |