WALTER AUFRICHT NASAL RETRACTOR - WALTER AUFRICHT NASAL RETRACTOR DOUBLE ENDED - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: WALTER AUFRICHT NASAL RETRACTOR DOUBLE ENDED

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More Product Details

Catalog Number

207-2928

Brand Name

WALTER AUFRICHT NASAL RETRACTOR

Version/Model Number

207-2928

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

KAL

Product Code Name

RETRACTOR, ENT

Device Record Status

Public Device Record Key

50915681-7ee8-4864-9bd1-6f51f9ca96d1

Public Version Date

October 12, 2018

Public Version Number

1

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