Vario-Soft-Bar-Pattern, - Vario-Soft-Bar-Pattern, joint snap-in, Matrices, - bredent GmbH & Co. KG

Duns Number:341086190

Device Description: Vario-Soft-Bar-Pattern, joint snap-in, Matrices, green 8 Pieces

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More Product Details

Catalog Number

43006270

Brand Name

Vario-Soft-Bar-Pattern,

Version/Model Number

43006270

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

-

Prescription Use (Rx)

-

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

EGG

Product Code Name

ATTACHMENT, PRECISION, ALL

Device Record Status

Public Device Record Key

bfcc69c7-dae8-48e5-8d42-57e60c2d9a63

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

EBRE430062709

Quantity per Package

1

Contains DI Package

EBRE430062700

Package Discontinue Date

September 21, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy

"BREDENT GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 38
2 A medical device with a moderate to high risk that requires special controls. 375