Polarfix™ Facet Screw System

GUDID 08800037586186

Innosys Co., Ltd.

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• Primary Device ID: 08800037586186
• NIH Device Record Key: 627456b7-440e-4747-8657-11c53b893076
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polarfix™ Facet Screw System
• Version Model Number: FS0050
• 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	08800037586186 [Primary]

FDA Product Code

• HTW: BIT, DRILL

Sterilization

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

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

[08800037586186]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-30
• Device Publish Date: 2024-01-22

On-Brand Devices [Polarfix™ Facet Screw System]

• 08800037500250: FSA5550N
• 08800037500243: FSA5545N
• 08800037500236: FSA5540N
• 08800037500229: FSA5535N
• 08800037500212: FSA5530N
• 08800037500205: FSA5525N
• 08800037500199: FSA4550N
• 08800037500182: FSA4545N
• 08800037500175: FSA4540N
• 08800037500168: FSA4535N
• 08800037500151: FSA4530N
• 08800037500144: FSA4525N
• 08800015994866: FS0080
• 08800015994859: FS0070
• 08800015994842: FS0060
• 08800015994835: FS0050
• 08800015994828: FS0040
• 08800015994811: FS0030
• 08800015994804: FS0020
• 08800015994798: FS0010
• 08800015994781: FSA5550
• 08800015994774: FSA5545
• 08800015994767: FSA5540
• 08800015994750: FSA5535
• 08800015994743: FSA5530
• 08800015994736: FSA5525
• 08800015994729: FSA4550
• 08800015994712: FSA4545
• 08800015994705: FSA4540
• 08800015994699: FSA4535
• 08800015994682: FSA4530
• 08800015994675: FSA4525
• 08800037586186: FS0050
• 08800037586179: FS0040
• 08800037586162: FS0010