Galaxy - PLIF Trial 10 - DIOMEDICAL CO.,LTD.

Duns Number:557795909

Device Description: PLIF Trial 10

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More Product Details

Catalog Number

SCPI-083

Brand Name

Galaxy

Version/Model Number

A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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

K122872

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral fusion device with bone graft, lumbar

Device Record Status

Public Device Record Key

bb5062df-7d4c-4f0c-8607-bcf60fe2b26e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 08, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DIOMEDICAL CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7203
U Unclassified 227