ENDOSCOPIC FOREHEAD LIFTER - ENDOSCOPIC FOREHEAD LIFTER #3 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: ENDOSCOPIC FOREHEAD LIFTER #3

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More Product Details

Catalog Number

207-953

Brand Name

ENDOSCOPIC FOREHEAD LIFTER

Version/Model Number

207-953

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

KAD

Product Code Name

ELEVATOR, ENT

Device Record Status

Public Device Record Key

37fc88f3-9c3e-4a5c-bbfa-1f983ac9972c

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

September 14, 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