LMA AIRWAY MANAGEMENT - LMA Unique™ (Silicone Cuff) Size 6 - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: LMA Unique™ (Silicone Cuff) Size 6

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More Product Details

Catalog Number

105300-000060

Brand Name

LMA AIRWAY MANAGEMENT

Version/Model Number

IPN041139

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

CAE

Product Code Name

AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Device Record Status

Public Device Record Key

22f6a05d-6b09-4272-851c-2c48f77bcad6

Public Version Date

February 22, 2021

Public Version Number

3

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

25060112313527

Quantity per Package

5

Contains DI Package

15060112313520

Package Discontinue Date

February 20, 2021

Package Status

Not in Commercial Distribution

Package Type

Carton

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26