Palo Alto ™ - CVBR LCM 23.25 MM - CARDINAL SPINE LLC

Duns Number:009915751

Device Description: CVBR LCM 23.25 MM

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More Product Details

Catalog Number

LCM 23.25 MM

Brand Name

Palo Alto ™

Version/Model Number

LCM 23.25 MM

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

PLR

Product Code Name

Spinal vertebral body replacement device - Cervical

Device Record Status

Public Device Record Key

3473709a-aac5-42fc-9e8e-87623de4c9e2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 20, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CARDINAL SPINE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1