ELEOS™ - Reamer Trial 13x120MM - ONKOS SURGICAL, INC.

Duns Number:080254074

Device Description: Reamer Trial 13x120MM

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More Product Details

Catalog Number

RT-13000-03N

Brand Name

ELEOS™

Version/Model Number

RT-13000-03N

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161520

Product Code Details

Product Code

HWT

Product Code Name

TEMPLATE

Device Record Status

Public Device Record Key

d8cb47d1-dd63-4549-b622-d8ebf990c3c2

Public Version Date

October 08, 2018

Public Version Number

1

DI Record Publish Date

September 06, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ONKOS SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 378
2 A medical device with a moderate to high risk that requires special controls. 231
3 A medical device with high risk that requires premarket approval 4