BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for - BritePro Max LED Fiber Optic Reusable - FLEXICARE MEDICAL LIMITED

Duns Number:504406273

Device Description: BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for Mini/Penli BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for Mini/Penlight Handle

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More Product Details

Catalog Number

-

Brand Name

BritePro Max LED Fiber Optic Reusable Laryngoscope Replacement Light Source for

Version/Model Number

041-814U

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Device Record Status

Public Device Record Key

3c01dc9a-0e9a-444e-8a4a-c02e953bb1b5

Public Version Date

February 03, 2020

Public Version Number

1

DI Record Publish Date

January 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FLEXICARE MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 715
2 A medical device with a moderate to high risk that requires special controls. 465