Catalog Number

5700882

Brand Name

Henry Schein

Version/Model Number

5700882

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"

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

K101958,K101958,K101958

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

73d09c10-08a3-4aa3-a4f2-b9bdbbc7e58d

Public Version Date

April 07, 2021

Public Version Number

3

DI Record Publish Date

September 26, 2018

Package DI Number

10304040070953

Quantity per Package

100

Contains DI Package

00304040070956

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case