IntuBrite Sterile - MAC 4 /MEDIUM SINGLE USE DISPOSABLE USE - SALTER LABS

Duns Number:022721133

Device Description: MAC 4 /MEDIUM SINGLE USE DISPOSABLE USE DISPOSABLE LARYNGOSCOPE SYSTEM-STERILE

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More Product Details

Catalog Number

S01-1024.C2015.C

Brand Name

IntuBrite Sterile

Version/Model Number

S01-1024.C2015.C

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"

Yes

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 Details

Product Code

CCW

Product Code Name

Laryngoscope, Rigid

Device Record Status

Public Device Record Key

fa4eee43-94ab-444b-9355-36d31d2a3675

Public Version Date

January 14, 2019

Public Version Number

1

DI Record Publish Date

December 13, 2018

Additional Identifiers

Package DI Number

10607411967914

Quantity per Package

5

Contains DI Package

00607411967917

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SALTER LABS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 865
2 A medical device with a moderate to high risk that requires special controls. 1134