SICKLE SCALER - SICKLE SCALER #109 SINGLE ENDED TAPERED POINT - SONTEC INSTRUMENTS, INC.

Duns Number:040729840

Device Description: SICKLE SCALER #109 SINGLE ENDED TAPERED POINT BLADE MODERATE SIZE LONG REACH

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More Product Details

Catalog Number

1102-SC109

Brand Name

SICKLE SCALER

Version/Model Number

1102-SC109

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

EMN

Product Code Name

SCALER, PERIODONTIC

Device Record Status

Public Device Record Key

a6da825f-0bfc-4d3d-a6bd-cd9c59d5b282

Public Version Date

September 10, 2019

Public Version Number

4

DI Record Publish Date

September 17, 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