Envision - 75 mm Cervical Plate Four Level - Ortho Development Corporation

Duns Number:876542390

Device Description: 75 mm Cervical Plate Four Level

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More Product Details

Catalog Number

-

Brand Name

Envision

Version/Model Number

154-5475

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2016

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

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

KWQ

Product Code Name

APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Device Record Status

Public Device Record Key

771e1d29-6a77-480d-8180-cda1e42d8b0f

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 31, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO DEVELOPMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3694
2 A medical device with a moderate to high risk that requires special controls. 3650