SUSTAIN

GUDID 00889095155051

SUSTAIN G, Radiolucent TPS Spacer, 8x22, 9mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095155051
• NIH Device Record Key: 0ee62b3f-b950-45b2-b775-c8d60a2ce765
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUSTAIN
• Version Model Number: 504.109CS
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095155051 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143578

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-08-27

On-Brand Devices [SUSTAIN]

• 00849044080056: SUSTAIN Radiolucent Spacer, Small, Narrow, 17mm
• 00849044080049: SUSTAIN Radiolucent Spacer, Small, Narrow, 15mm
• 00849044080032: SUSTAIN Radiolucent Spacer, Small, Narrow, 13mm
• 00849044080025: SUSTAIN Radiolucent Spacer, Small, Narrow, 11mm
• 00849044080018: SUSTAIN Radiolucent Spacer, Small, Narrow, 9mm
• 00849044080001: SUSTAIN Radiolucent Spacer, Small, Narrow, 7mm
• 00849044079999: SUSTAIN Radiolucent Spacer, Small, 18mm Length, 17mm
• 00849044079982: SUSTAIN Radiolucent Spacer, Small, 18mm Length, 15mm
• 00849044079975: SUSTAIN Radiolucent Spacer, Small, 18mm Length, 13mm
• 00849044079968: SUSTAIN Radiolucent Spacer, Small, 18mm Length, 11mm
• 00849044079951: SUSTAIN Radiolucent Spacer, Small, 18mm Length, 9mm
• 00849044079944: SUSTAIN Radiolucent Spacer, Small, 21 mm
• 00849044079937: SUSTAIN Radiolucent Spacer, Small, 19mm
• 00849044079920: SUSTAIN Radiolucent Spacer, Small, 17mm
• 00849044079913: SUSTAIN Radiolucent Spacer, Small, 15mm
• 00849044079906: SUSTAIN Radiolucent Spacer, Small, 13mm
• 00849044079890: SUSTAIN Radiolucent Spacer, Small, 11mm
• 00849044079883: SUSTAIN Radiolucent Spacer, Small, 9mm
• 00849044079876: SUSTAIN Radiolucent Spacer, Small, 7mm
• 00849044079869: SUSTAIN Spacer, Small, Narrow 17mm
• 00849044079852: SUSTAIN Spacer, Small, Narrow 15mm
• 00849044079845: SUSTAIN Spacer, Small, Narrow 13mm
• 00849044079838: SUSTAIN Spacer, Small, Narrow 11mm
• 00849044079821: SUSTAIN Spacer, Small, Narrow 9mm
• 00849044079814: SUSTAIN Spacer, Small, Narrow 7mm
• 00849044079807: SUSTAIN Spacer, Small, 17mm
• 00849044079791: SUSTAIN Spacer, Small, 15mm
• 00849044079784: SUSTAIN Spacer, Small, 13mm
• 00849044079777: SUSTAIN Spacer, Small, 11mm
• 00849044079760: SUSTAIN Spacer, Small, 9mm
• 00849044079753: SUSTAIN Spacer, Small, 7mm
• 00849044079722: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 17mm
• 00849044079715: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 15mm
• 00849044079708: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 14mm
• 00849044079692: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 13mm
• 00849044079685: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 12mm
• 00849044079678: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 11mm
• 00849044079661: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 10mm
• 00849044079654: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 9mm
• 00849044079647: SUSTAIN Radiolucent Spacer, Oblique, 12x26, 8mm
• 00849044079630: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 17mm
• 00849044079623: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 15mm
• 00849044079616: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 14mm
• 00849044079609: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 13mm
• 00849044079593: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 12mm
• 00849044079586: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 11mm
• 00849044079579: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 10mm
• 00849044079562: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 9mm
• 00849044079555: SUSTAIN Radiolucent Spacer, Oblique, 12x30, 8mm
• 00849044079548: SUSTAIN Radiolucent Spacer, Oblique, 10x30, 17mm