Duns Number:131489882
Device Description: GLIDESHEATH SLENDER Nitinol Hydrophilic Coated Introducer Sheath
Catalog Number
50-1070
Brand Name
GLIDESHEATH SLENDER
Version/Model Number
50-1070
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
585e626c-1db8-409d-818c-c17e06c09d5c
Public Version Date
June 07, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
30389701011371
Quantity per Package
5
Contains DI Package
00389701011370
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 |