Quinelato - Extractor Mc Call no. 11-12 - Schobell Industrial Ltda

Duns Number:899060826

Device Description: Extractor Mc Call no. 11-12

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More Product Details

Catalog Number

QD.015.12

Brand Name

Quinelato

Version/Model Number

QD.015.12

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

7eaf3c00-91f9-4255-ba31-c26358bbd43f

Public Version Date

November 01, 2022

Public Version Number

1

DI Record Publish Date

October 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCHOBELL INDUSTRIAL LTDA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 545