SUSTAIN - SUSTAIN Radiolucent Medium Parallel, Bead, 9mm - GLOBUS MEDICAL, INC.

Duns Number:139105691

Device Description: SUSTAIN Radiolucent Medium Parallel, Bead, 9mm

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More Product Details

Catalog Number

-

Brand Name

SUSTAIN

Version/Model Number

304.269

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

Yes

Prescription Use (Rx)

-

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

MQP

Product Code Name

SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Record Status

Public Device Record Key

b8645f9a-a913-4fb9-bb91-18a82b4c6193

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

November 06, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GLOBUS MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4975
2 A medical device with a moderate to high risk that requires special controls. 34645
3 A medical device with high risk that requires premarket approval 57
U Unclassified 232