Catalog Number

CELEROMARK-2S

Brand Name

CELEROMARK

Version/Model Number

CELEROMARK-2S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K023450,K023450

Product Code

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Public Device Record Key

7ed2c0a1-ce26-4586-b2f2-a6f7c650fde2

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 04, 2015

Package DI Number

15420045503380

Quantity per Package

10

Contains DI Package

05420045503383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX