Cervical Cage - Cervical Cage 14AP X 16ML X 09HT - Eisertech, LLC

Duns Number:965627297

Device Description: Cervical Cage 14AP X 16ML X 09HT

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More Product Details

Catalog Number

100018-14169

Brand Name

Cervical Cage

Version/Model Number

100018-14169

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 10, 2017

Issuing Agency

In HIBCC

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

ODP

Product Code Name

Intervertebral Fusion Device With Bone Graft, Cervical

Device Record Status

Public Device Record Key

73df2e59-d3cb-4280-9bdb-f3bbc2a5ea94

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

April 06, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EISERTECH, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 459