SMITH-PETERSEN OSTEOTOME - SMITH-PETERSEN OSTEOTOME CURVED TIP - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: SMITH-PETERSEN OSTEOTOME CURVED TIP

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More Product Details

Catalog Number

330-621

Brand Name

SMITH-PETERSEN OSTEOTOME

Version/Model Number

330-621

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

HWM

Product Code Name

OSTEOTOME

Device Record Status

Public Device Record Key

b2a0b9ae-6d9b-4a61-881b-71b58c9cae88

Public Version Date

November 26, 2018

Public Version Number

1

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