Buck Ear Curette - Buck Ear Curette Round Handle Blunt Angle Size 00 - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: Buck Ear Curette Round Handle Blunt Angle Size 00 Quantum

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More Product Details

Catalog Number

-

Brand Name

Buck Ear Curette

Version/Model Number

467-380Q

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

JYG

Product Code Name

CURETTE, EAR

Device Record Status

Public Device Record Key

aba0fe47-4665-4ccc-8bc6-21c000b2a8b2

Public Version Date

November 17, 2021

Public Version Number

1

DI Record Publish Date

November 09, 2021

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