Catalog Number

26709

Brand Name

EXEL Scalp Vein Set

Version/Model Number

26709

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

-

Product Code

FPA

Product Code Name

Set, Administration, Intravascular

Public Device Record Key

cd59d8c7-e9dc-4687-8dc7-161df3ed7b7d

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

September 20, 2016

Package DI Number

20020221267093

Quantity per Package

10

Contains DI Package

10020221267096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-