Catalog Number

11532568

Brand Name

Atellica CH Lactate_2 (Lac_2)

Version/Model Number

11532568

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

-

Product Code

KHP

Product Code Name

ACID, LACTIC, ENZYMATIC METHOD

Public Device Record Key

f8b86d4e-ec3b-4aeb-a341-0602103f206d

Public Version Date

November 18, 2021

Public Version Number

2

DI Record Publish Date

August 19, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-