PRIMA™ OCT Spinal System

GUDID 08800037596734

Innosys Co., Ltd.

Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter Surgical instrument/implant depth limiter

• Primary Device ID: 08800037596734
• NIH Device Record Key: d4eba373-8e3f-4759-a389-d0bdefb2a1aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMA™ OCT Spinal System
• Version Model Number: SO0230
• Company DUNS: 688811082
• Company Name: Innosys Co., Ltd.
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037596734 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

[08800037596734]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-18
• Device Publish Date: 2024-03-09

On-Brand Devices [PRIMA™ OCT Spinal System]

• 08800037585875: SO0360
• 08800037585868: SO0350
• 08800037585851: SO0330
• 08800037585844: SO0250
• 08800037585837: SO0090
• 08800037585820: SO0080
• 08800037585813: SO0070
• 08800037585806: SO0040
• 08800037585790: SO0020
• 08800037596734: SO0230