N.A. - McLaughlin Bennett 5.0 Archwires steel Ball - Forestadent Bernhard Förster GmbH

Duns Number:316074384

Device Description: McLaughlin Bennett 5.0 Archwires steel Ball posted 38mm Square-F. max. .019"x.025"

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More Product Details

Catalog Number

-

Brand Name

N.A.

Version/Model Number

-209S3848

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

DZC

Product Code Name

WIRE, ORTHODONTIC

Device Record Status

Public Device Record Key

08efa026-6864-458b-bf3d-ec3b6c9d0e41

Public Version Date

October 02, 2019

Public Version Number

1

DI Record Publish Date

September 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORESTADENT BERNHARD FÖRSTER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5082
2 A medical device with a moderate to high risk that requires special controls. 941