PRIMA™ OCT Spinal System

GUDID 08800037575456

U&I CORPORATION

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 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: 08800037575456
• NIH Device Record Key: 4816df34-438f-4265-890a-26d7784df82a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIMA™ OCT Spinal System
• Version Model Number: SO0280
• Company DUNS: 688811082
• Company Name: U&I 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: false
• Lot Batch: true
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800037575456 [Primary]

FDA Product Code

• HTJ: GAUGE, DEPTH

Sterilization

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

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

[08800037575456]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-17
• Device Publish Date: 2023-04-08

On-Brand Devices [PRIMA™ OCT Spinal System]

• 08800037575456: SO0280
• 08800037575449: SO0250
• 08800037575432: SO0160