GUBISCH AUFRICHT NASAL RETRACTOR - G. AUFRICHT NASAL RETRACTOR SOLID TAPERED BLADE - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: G. AUFRICHT NASAL RETRACTOR SOLID TAPERED BLADE

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More Product Details

Catalog Number

207-2920

Brand Name

GUBISCH AUFRICHT NASAL RETRACTOR

Version/Model Number

207-2920

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

7e13a0a6-e63a-4be9-a531-0cb360eda725

Public Version Date

November 20, 2019

Public Version Number

2

DI Record Publish Date

October 24, 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