HILINE

GUDID 00193982506292

Offset Band Clamp, 6.35-6.5

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00193982506292
• NIH Device Record Key: f18cd575-833a-4e7a-94bd-08046d47e5cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HILINE
• Version Model Number: 1230.1165
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00193982506292 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230565

FDA Product Code

• OWI: Bone fixation cerclage, sublaminar

Sterilization

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

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

[00193982506292]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

On-Brand Devices [HILINE]

• 00193982565312: 4mm Band, Needle Tip
• 00193982565305: 6mm Band, Malleable Leader
• 00193982565299: 4mm Band, Malleable Leader
• 00193982518837: Adjustable Ratcheting Tensioner
• 00193982506544: Overhead Ratcheting Tensioner
• 00193982506537: Ratcheting Tensioner
• 00193982506520: Spool Thumb Driver
• 00193982506513: Spool Wrench
• 00193982506490: Inserter Sleeve
• 00193982506476: Inserter Fork, Short
• 00193982506469: Fixed Handle Attachment
• 00193982506452: Tension Indicator
• 00193982506445: Anchor Removal Tool
• 00193982506292: Offset Band Clamp, 6.35-6.5
• 00193982506285: Offset Band Clamp, 5.5-6.0
• 00193982506278: Offset Band Clamp, 4.5-4.75
• 00193982506261: Offset Band Clamp, 3.5-4.0
• 00193982506254: Inline Band Clamp, 6.35-6.5
• 00193982506247: Inline Band Clamp, 5.5-6.0
• 00193982506230: Inline Band Clamp, 4.5-4.75
• 00193982506223: Inline Band Clamp, 3.5-4.0
• 00193982506216: Free Band Clamp