MICHEL RHINOSCOPIC MIRROR - MICHEL RHINOSCOPIC MIRROR #2 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: MICHEL RHINOSCOPIC MIRROR #2

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More Product Details

Catalog Number

502-202

Brand Name

MICHEL RHINOSCOPIC MIRROR

Version/Model Number

502-202

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 28, 2019

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

-

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

5e17bfc6-1b9c-40f5-9f81-cccc3067ddae

Public Version Date

May 29, 2019

Public Version Number

2

DI Record Publish Date

May 03, 2019

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