Catalog Number

C61W-D01-L

Brand Name

HYDRIM C61W G4 Instrument Washer

Version/Model Number

C61W-D01-L

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

LDS

Product Code Name

Device, Pasteurization, Hot Water

Public Device Record Key

f793d464-6a2a-4728-a624-e6a083e6f7e4

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

January 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-