Mixing Tips - Mixing tips, red, ø 4.0 mm500 tips - Kettenbach GmbH & Co. KG

Duns Number:316803246

Device Description: Mixing tips, red, ø 4.0 mm500 tips

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More Product Details

Catalog Number

17254

Brand Name

Mixing Tips

Version/Model Number

17254

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

EID

Product Code Name

Syringe, Restorative And Impression Material

Device Record Status

Public Device Record Key

a8463728-ec5f-4b0c-98aa-38ea6b2f401d

Public Version Date

December 28, 2020

Public Version Number

1

DI Record Publish Date

December 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KETTENBACH 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 27
2 A medical device with a moderate to high risk that requires special controls. 248