ELEOS™ - ELEOS™ INSTRUMENTATION TRAY, AUGMENT PREPARATION - ONKOS SURGICAL, INC.

Duns Number:080254074

Device Description: ELEOS™ INSTRUMENTATION TRAY, AUGMENT PREPARATION AND TRIALING INSTRUMENTS, TRAY 13

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More Product Details

Catalog Number

001-03-00013

Brand Name

ELEOS™

Version/Model Number

001-03-00013

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

-

Product Code Details

Product Code

FSM

Product Code Name

TRAY, SURGICAL, INSTRUMENT

Device Record Status

Public Device Record Key

e0c08903-835a-4d34-8089-6684c7f06ace

Public Version Date

September 16, 2022

Public Version Number

8

DI Record Publish Date

March 20, 2017

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