V-STRUT Vertebral Implant - V-STRUT© Vertebral Implant 5.5-L55 - HYPREVENTION

Duns Number:262372421

Device Description: V-STRUT© Vertebral Implant 5.5-L55

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More Product Details

Catalog Number

35555

Brand Name

V-STRUT Vertebral Implant

Version/Model Number

35555

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

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

LOD

Product Code Name

Bone Cement

Device Record Status

Public Device Record Key

db54d578-975b-4812-a623-89144afe1df9

Public Version Date

March 15, 2021

Public Version Number

1

DI Record Publish Date

March 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYPREVENTION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 20