SILC

GUDID 00889095493252

SILC 4mm Cord Tensioner

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00889095493252
• NIH Device Record Key: 36e34ca3-6d27-4e4b-99fd-8f0d0bc834a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SILC
• Version Model Number: 6116.3204
• 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	00889095493252 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172417

FDA Product Code

• OWI: Bone fixation cerclage, sublaminar

Sterilization

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

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

[00889095493252]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-21
• Device Publish Date: 2020-07-13

On-Brand Devices [SILC]

• 00889095029215: SILC 6.0-6.5mm Inline Clamp
• 00889095029208: SILC 5.5mm Inline Clamp
• 00889095029192: SILC 4.5-4.75mm Inline Clamp
• 00889095493252: SILC 4mm Cord Tensioner
• 00889095493191: SILC 4.75-5.5mm Inline 4mm Cord Clamp
• 00193982146160: SILC Cord, 350mm
• 00193982146153: SILC Cord, 250mm