Laryngeal Mask Airways - Laryngeal Mask Airways, Silicone Reinforced, 1.0 - DYNAREX CORPORATION

Duns Number:008124539

Device Description: Laryngeal Mask Airways, Silicone Reinforced, 1.0 mm, Sterile

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More Product Details

Catalog Number

-

Brand Name

Laryngeal Mask Airways

Version/Model Number

5032

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

Yes

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

CAE

Product Code Name

Airway, Oropharyngeal, Anesthesiology

Device Record Status

Public Device Record Key

471f076c-bc75-4f93-986b-7fe1de03318d

Public Version Date

November 19, 2020

Public Version Number

1

DI Record Publish Date

November 11, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DYNAREX CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 694
2 A medical device with a moderate to high risk that requires special controls. 226
3 A medical device with high risk that requires premarket approval 2