3M™ RelyX™ - 3M™ RelyX™ Fiber Post 3D Glass Fiber Post - Size - 3M Deutschland GmbH

Duns Number:315731711

Device Description: 3M™ RelyX™ Fiber Post 3D Glass Fiber Post - Size 1 (Yellow), 56949

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More Product Details

Catalog Number

56949

Brand Name

3M™ RelyX™

Version/Model Number

56949

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

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

ELR

Product Code Name

POST, ROOT CANAL

Device Record Status

Public Device Record Key

6254f880-950e-4c26-b5fc-8322fba20647

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"3M DEUTSCHLAND GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 232
2 A medical device with a moderate to high risk that requires special controls. 563
U Unclassified 3