Catalog Number

-

Brand Name

Rebar

Version/Model Number

105-5081-153

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

K210114

Product Code

KRA

Product Code Name

Catheter, continuous flush

Public Device Record Key

d7978f1a-5dfd-45f3-b3c0-38706f2fd8ca

Public Version Date

March 07, 2022

Public Version Number

1

DI Record Publish Date

February 27, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-