Catalog Number

215407

Brand Name

PATHSEEKER

Version/Model Number

215407

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

-

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

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Public Device Record Key

fc0b3e1c-c137-4a8b-9e1e-7f6feaeaf2e2

Public Version Date

September 16, 2022

Public Version Number

9

DI Record Publish Date

September 01, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-