Catalog Number

SL-12

Brand Name

SurgiLux™

Version/Model Number

SL-12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

Yes

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

FTD

Product Code Name

Lamp, Surgical

Public Device Record Key

c1ec1083-5af4-4543-8987-535d8dac1283

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

July 01, 2019

Package DI Number

M710SL122

Quantity per Package

12

Contains DI Package

M710SL120

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser & 1-pack