Perfix™ Iliac Screw System

GUDID 08800037583215

Innosys Co., Ltd.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 08800037583215
• NIH Device Record Key: 97ee6d63-6cf4-4c30-bed5-f3ee07a7f8c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Perfix™ Iliac Screw System
• Version Model Number: SL0010
• 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	08800037583215 [Primary]

FDA Product Code

• HXX: SCREWDRIVER

Sterilization

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

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

[08800037583215]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-28
• Device Publish Date: 2023-09-20

On-Brand Devices [Perfix™ Iliac Screw System]

• 08800015931519: SL0214
• 08800037583222: SL0030
• 08800037583215: SL0010