PICC WAND - The PICC WAND Safety Introducer with Peelable - ACCESS SCIENTIFIC, LLC

Duns Number:079290879

Device Description: The PICC WAND Safety Introducer with Peelable Sheath and Integral Needle Protection

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More Product Details

Catalog Number

91012

Brand Name

PICC WAND

Version/Model Number

6Fr

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

K111138,K111138,K111138

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

4e8a7088-c664-48bf-bb39-8042412b3775

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

30859821006156

Quantity per Package

18

Contains DI Package

20859821006159

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