Fomon Rasp - Fomon Rasp Double Ended Angled Single Sided - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Fomon Rasp Double Ended Angled Single Sided Tungsten Carbide Inserts #1/2

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More Product Details

Catalog Number

-

Brand Name

Fomon Rasp

Version/Model Number

345-281A

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"

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

KBA

Product Code Name

RASP, NASAL

Device Record Status

Public Device Record Key

aaf91f96-edb8-4af1-b136-42460255f823

Public Version Date

June 24, 2022

Public Version Number

1

DI Record Publish Date

June 16, 2022

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