Omnia Medical VBR - Omnia Medical VBR, Mallet - OMNIA MEDICAL, LLC

Duns Number:079467378

Device Description: Omnia Medical VBR, Mallet

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More Product Details

Catalog Number

06-6V-MAL1

Brand Name

Omnia Medical VBR

Version/Model Number

06-6V-MAL1

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

-

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

K172323

Product Code Details

Product Code

MQP

Product Code Name

Spinal Vertebral Body Replacement Device

Device Record Status

Public Device Record Key

82762366-262f-4808-81ec-2b06bd3df733

Public Version Date

September 10, 2019

Public Version Number

4

DI Record Publish Date

February 05, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OMNIA MEDICAL, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 112
U Unclassified 1