SUSTAIN-IR

GUDID 00889095091021

SUSTAIN-IR Spacer, 9 x 34mm, 7°, 13mm

GLOBUS MEDICAL, INC.

Metallic spinal interbody fusion cage

• Primary Device ID: 00889095091021
• NIH Device Record Key: da36d7a4-645c-43a0-8d64-d0d4418ef32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUSTAIN-IR
• Version Model Number: 3145.1913
• 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: false
• 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

• Length: 34 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889095091021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151665

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00889095091021]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-24
• Device Publish Date: 2016-09-28

On-Brand Devices [SUSTAIN-IR]

• 00889095303407: Inserter Fork, Straight
• 00889095303391: Inserter Fork, Straight, Short
• 00889095303360: Inserter Fork
• 00889095303353: Inserter Fork, Short
• 00889095303322: Inserter Shaft
• 00889095093377: SUSTAIN-IR Spacer, 9 x 34mm, 22°, 17mm
• 00889095093353: SUSTAIN-IR Spacer, 9 x 34mm, 19°, 16mm
• 00889095093339: SUSTAIN-IR Spacer, 9 x 34mm, 19°, 15mm
• 00889095093315: SUSTAIN-IR Spacer, 9 x 30mm, 22°, 17mm
• 00889095093292: SUSTAIN-IR Spacer, 9 x 30mm, 20°, 16mm
• 00889095093278: SUSTAIN-IR Spacer, 9 x 30mm, 20°, 15mm
• 00889095093254: SUSTAIN-IR Spacer, 9 x 30mm, 19°, 14mm
• 00889095093230: SUSTAIN-IR Spacer, 9 x 30mm, 19°, 13mm
• 00889095093216: SUSTAIN-IR Spacer, 9 x 26mm, 22°, 17mm
• 00889095093193: SUSTAIN-IR Spacer, 9 x 26mm, 22°, 16mm
• 00889095093179: SUSTAIN-IR Spacer, 9 x 26mm, 22°, 15mm
• 00889095093155: SUSTAIN-IR Spacer, 9 x 22mm, 22°, 17mm
• 00889095093131: SUSTAIN-IR Spacer, 9 x 22mm, 22°, 16mm
• 00889095093117: SUSTAIN-IR Spacer, 9 x 22mm, 22°, 15mm
• 00889095093094: SUSTAIN-IR Spacer, 9 x 22mm, 22°, 14mm
• 00889095093070: SUSTAIN-IR Spacer, 9 x 22mm, 22°, 13mm
• 00889095093056: SUSTAIN-IR Spacer, 9 x 22mm, 19°, 12mm
• 00889095092554: SUSTAIN-IR Spacer, 9 x 34mm, 15°, 17mm
• 00889095092530: SUSTAIN-IR Spacer, 9 x 34mm, 15°, 16mm
• 00889095092516: SUSTAIN-IR Spacer, 9 x 34mm, 15°, 15mm
• 00889095092493: SUSTAIN-IR Spacer, 9 x 34mm, 13°, 14mm
• 00889095092479: SUSTAIN-IR Spacer, 9 x 34mm, 13°, 13mm
• 00889095092455: SUSTAIN-IR Spacer, 9 x 34mm, 11°, 12mm
• 00889095092431: SUSTAIN-IR Spacer, 9 x 34mm, 11°, 11mm
• 00889095092417: SUSTAIN-IR Spacer, 9 x 30mm, 15°, 17mm
• 00889095092394: SUSTAIN-IR Spacer, 9 x 30mm, 15°, 16mm
• 00889095092370: SUSTAIN-IR Spacer, 9 x 30mm, 15°, 15mm
• 00889095092356: SUSTAIN-IR Spacer, 9 x 30mm, 15°, 14mm
• 00889095092332: SUSTAIN-IR Spacer, 9 x 30mm, 15°, 13mm
• 00889095092318: SUSTAIN-IR Spacer, 9 x 30mm, 13°, 12mm
• 00889095092295: SUSTAIN-IR Spacer, 9 x 30mm, 11°, 11mm
• 00889095092271: SUSTAIN-IR Spacer, 9 x 30mm, 11°, 10mm
• 00889095092257: SUSTAIN-IR Spacer, 9 x 26mm, 15°, 17mm
• 00889095092233: SUSTAIN-IR Spacer, 9 x 26mm, 15°, 16mm
• 00889095092219: SUSTAIN-IR Spacer, 9 x 26mm, 15°, 15mm
• 00889095092196: SUSTAIN-IR Spacer, 9 x 26mm, 15°, 14mm
• 00889095092172: SUSTAIN-IR Spacer, 9 x 26mm, 15°, 13mm
• 00889095092158: SUSTAIN-IR Spacer, 9 x 26mm, 15°, 12mm
• 00889095092134: SUSTAIN-IR Spacer, 9 x 26mm, 13°, 11mm
• 00889095092110: SUSTAIN-IR Spacer, 9 x 26mm, 12°, 10mm
• 00889095092097: SUSTAIN-IR Spacer, 9 x 22mm, 15°, 17mm
• 00889095092073: SUSTAIN-IR Spacer, 9 x 22mm, 15°, 16mm
• 00889095092059: SUSTAIN-IR Spacer, 9 x 22mm, 15°, 15mm
• 00889095092035: SUSTAIN-IR Spacer, 9 x 22mm, 15°, 14mm
• 00889095092011: SUSTAIN-IR Spacer, 9 x 22mm, 15°, 13mm