LARYNGEAL MIRROR - LARYNGEAL MIRROR WITH HANDLE #5 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: LARYNGEAL MIRROR WITH HANDLE #5

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More Product Details

Catalog Number

502-252

Brand Name

LARYNGEAL MIRROR

Version/Model Number

502-252

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)

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

KAI

Product Code Name

MIRROR, ENT

Device Record Status

Public Device Record Key

f798f357-9188-4a60-9855-ef3e12d0cdc7

Public Version Date

October 22, 2018

Public Version Number

2

DI Record Publish Date

September 11, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SONTEC INSTRUMENTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10108
2 A medical device with a moderate to high risk that requires special controls. 3414