Zuma 95-5825

GUDID 10889981097547

Wedge Distractor, 10mm

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic surgical distractor, internal

• Primary Device ID: 10889981097547
• NIH Device Record Key: c135f19a-ffa9-4dcf-a3e0-a54c235c2cf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zuma
• Version Model Number: 95-5825
• Catalog Number: 95-5825
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981097547 [Primary]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[10889981097547]

Moist Heat or Steam Sterilization

[10889981097547]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-31

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• 10889981097448: Modular Bullet Paddle Distractor 13mm
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• 10889981097424: Modular Bullet Paddle Distractor 10mm
• 10889981097417: Modular Bullet Paddle Distractor 8mm
• 10889981097394: Mask Handle
• 10889981097387: Fixed Mask AIO Guide
• 10889981097370: Variable Mask AIO Guide
• 10889981097349: Mask, 18mm
• 10889981097332: Mask, 16mm
• 10889981097325: Mask, 14mm
• 10889981097318: Mask, 12mm
• 10889981097301: Mask, 10mm
• 10889981097295: Slotted Mallet
• 10889981097264: Paddle Distractor, 18mm
• 10889981097257: Paddle Distractor, 17mm
• 10889981097240: Paddle Distractor, 16mm
• 10889981097233: Paddle Distractor, 15mm
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• 10889981097110: Zuma 6.0mm Bone Screw Caddy
• 10889981097103: Ratchet Handle
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