Catalog Number

-

Brand Name

Suremark

Version/Model Number

1.8mm lead ball on 15mm label

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JAC

Product Code Name

System, X-Ray, Film Marking, Radiographic

Public Device Record Key

f527e887-39aa-440e-a9b5-961a2b9db88d

Public Version Date

October 18, 2021

Public Version Number

1

DI Record Publish Date

October 08, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-