CVC WAND XL - The CVC WAND Safety Introducer with Valved - ACCESS SCIENTIFIC, LLC

Duns Number:079290879

Device Description: The CVC WAND Safety Introducer with Valved Peelabel Sheath

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More Product Details

Catalog Number

93102

Brand Name

CVC WAND XL

Version/Model Number

7Fr

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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"

Yes

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 Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

434d5e6f-ca0f-4039-bb2f-1a4bbadbfd61

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

30859821006125

Quantity per Package

18

Contains DI Package

20859821006128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Overpack

"ACCESS SCIENTIFIC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 59