Catalog Number

C33SDS554311S3

Brand Name

iCE Surgical Light

Version/Model Number

iCE30m

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

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Public Device Record Key

672c9847-9b47-4de2-b9c7-690b213710cb

Public Version Date

June 29, 2022

Public Version Number

1

DI Record Publish Date

June 21, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-