Slimplicity Plus Anterior Cervical Plating System - Plate Bender Anvil, Large - PRECISION SPINE, INC.

Duns Number:079398589

Device Description: Plate Bender Anvil, Large

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More Product Details

Catalog Number

66-PB-0022

Brand Name

Slimplicity Plus Anterior Cervical Plating System

Version/Model Number

66-PB-0022

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

HXW

Product Code Name

Bender

Device Record Status

Public Device Record Key

f787767c-d84a-4a8f-ae83-eb48d92191ad

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