APEX Spine System - Large Polyaxial Screwdriver - SPINECRAFT, LLC

Duns Number:783908713

Device Description: Large Polyaxial Screwdriver

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More Product Details

Catalog Number

6000-89-LG-H

Brand Name

APEX Spine System

Version/Model Number

6000-89-LG-H

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"

Yes

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

41f1b8c4-86af-487c-b2ca-31d8117a7511

Public Version Date

October 19, 2021

Public Version Number

1

DI Record Publish Date

October 11, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPINECRAFT, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1247
2 A medical device with a moderate to high risk that requires special controls. 15504