Catalog Number

-

Brand Name

Sterimed

Version/Model Number

BD92126

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IZI

Product Code Name

System, X-Ray, Angiographic

Public Device Record Key

b8b51cc8-6e0b-4cf8-bc9c-aa924bb93d98

Public Version Date

October 07, 2021

Public Version Number

1

DI Record Publish Date

September 29, 2021

Package DI Number

10860001790297

Quantity per Package

25

Contains DI Package

00860001790290

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case