Vault C ACDF System - Streamline Insertion Tip - PRECISION SPINE, INC.

Duns Number:079398589

Device Description: Streamline Insertion Tip

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More Product Details

Catalog Number

37-IN-0428

Brand Name

Vault C ACDF System

Version/Model Number

37-IN-0428

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

FZX

Product Code Name

Guide, Surgical, Instrument

Device Record Status

Public Device Record Key

bf3cb2a6-d834-489e-aaa4-b51aea7cbe81

Public Version Date

April 05, 2019

Public Version Number

1

DI Record Publish Date

March 28, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRECISION SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1423
2 A medical device with a moderate to high risk that requires special controls. 4960
U Unclassified 26