Duns Number:788472314
Device Description: 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 -
Catalog Number
7008
Brand Name
Disposable Tear-Away Vascular Introducer Set
Version/Model Number
7008
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
K932370,K932370,K932370
Product Code
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
8714cc7d-9c79-4fac-8727-02be4def2e8c
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
November 10, 2018
Package DI Number
10813079020186
Quantity per Package
10
Contains DI Package
00813079020189
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |