Ethos Button CL - RIVERPOINT MEDICAL, LLC

Duns Number:964053560

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More Product Details

Catalog Number

-

Brand Name

Ethos Button CL

Version/Model Number

HNM-OBCL-TI-20

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)

-

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

MBI

Product Code Name

Fastener, Fixation, Nondegradable, Soft Tissue

Device Record Status

Public Device Record Key

a7ec3f12-ce31-4229-b3e2-791198a0c49e

Public Version Date

March 21, 2019

Public Version Number

4

DI Record Publish Date

January 30, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RIVERPOINT MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 12
2 A medical device with a moderate to high risk that requires special controls. 1369
U Unclassified 8