SH 77-3 Oropharyngeal Airway - Oropharyngeal airway allows a fast and easy way - INSTRUMENTATION INDUSTRIES, INCORPORATED

Duns Number:053146767

Device Description: Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding th Oropharyngeal airway allows a fast and easy way to establish a patent airway by holding the tongue up and out of the way. Size - 60 mm.

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More Product Details

Catalog Number

-

Brand Name

SH 77-3 Oropharyngeal Airway

Version/Model Number

SH 77-3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

39755e29-17e5-4c76-9dae-1da9be44425d

Public Version Date

March 25, 2019

Public Version Number

1

DI Record Publish Date

March 16, 2019

Additional Identifiers

Package DI Number

M996SH7735

Quantity per Package

50

Contains DI Package

M996SH7730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Polybag

"INSTRUMENTATION INDUSTRIES, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 229
2 A medical device with a moderate to high risk that requires special controls. 71