Hexanium® ACIF - Ti Standard Cervical Tray - SPINEVISION

Duns Number:390377518

Device Description: Ti Standard Cervical Tray

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More Product Details

Catalog Number

-

Brand Name

Hexanium® ACIF

Version/Model Number

AC2-TRAY111

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

-

Product Code Details

Product Code

OJH

Product Code Name

Orthopedic Tray

Device Record Status

Public Device Record Key

cd512227-10d4-47ca-8b11-58e68ed7e593

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

November 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINEVISION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 603
2 A medical device with a moderate to high risk that requires special controls. 1751