Catalog Number

11206236

Brand Name

Atellica IM BR

Version/Model Number

11206236

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K982680,K982680

Product Code

MOI

Product Code Name

SYSTEM, TEST, IMMUNOLOGICAL, ANTIGEN, TUMOR

Public Device Record Key

f3e5abd8-d82d-45a7-b4f5-eb5e19c74b97

Public Version Date

November 18, 2021

Public Version Number

3

DI Record Publish Date

May 31, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-