Catalog Number

C2000W-E208

Brand Name

Sterling C2000

Version/Model Number

C2000W-E208

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MEC

Product Code Name

Disinfector, medical devices

Public Device Record Key

57526e0b-afa5-4d54-91d5-da972e1c3aee

Public Version Date

January 25, 2021

Public Version Number

1

DI Record Publish Date

January 16, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-