Duns Number:595138793
Device Description: Kits contents: Precutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.35mm x Kits contents: Precutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.35mm x ID 2.51mm x 10cm and Dilator; Guidewire 0.9 x 450mm; Introducer 1.4 x 70mm; Stopcock
Catalog Number
680130
Brand Name
SHEATH INTRO POP KIT 8FR L5 MULT=5/50
Version/Model Number
680130
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
acbaea79-f8cb-468e-b22e-90b4185338ac
Public Version Date
March 05, 2020
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
50886333601306
Quantity per Package
50
Contains DI Package
00886333601301
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Tray
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 392 |