SUSTAIN

GUDID 00193982185244

Inserter T-Handle, long

GLOBUS MEDICAL, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 00193982185244
• NIH Device Record Key: 026a24e0-16e2-4ec7-a240-c1c4c5ef2928
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUSTAIN
• Version Model Number: 6145.1003
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982185244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181357

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

[00193982185244]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-27
• Device Publish Date: 2021-01-19

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