BMT Medizintechnik GmbH - SCALER TOWNER-JACQUETTE, #H5/33 - BMT Medizintechnik GmbH

Duns Number:342582423

Device Description: SCALER TOWNER-JACQUETTE, #H5/33

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More Product Details

Catalog Number

719-125

Brand Name

BMT Medizintechnik GmbH

Version/Model Number

719-125

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

EMN

Product Code Name

SCALER, PERIODONTIC

Device Record Status

Public Device Record Key

56cd1b5c-e0dc-41aa-8273-8ca0ddabf2fa

Public Version Date

May 13, 2020

Public Version Number

1

DI Record Publish Date

May 05, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BMT MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2079
2 A medical device with a moderate to high risk that requires special controls. 1