OPTIMA™ Spinal System

GUDID 08800247357354

CG MedTech Co.,Ltd.

Surgical screwdriver, reusable

• Primary Device ID: 08800247357354
• NIH Device Record Key: eca2325a-1282-4798-aeac-6cbe101faf37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OPTIMA™ Spinal System
• Version Model Number: SP0017
• Company DUNS: 688811082
• Company Name: CG MedTech 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	08800247357354 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

[08800247357354]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-24
• Device Publish Date: 2025-02-16

Devices Manufactured by CG MedTech Co.,Ltd.

• 08800247357217 - INNOVERSE Spinal System: 2025-02-24
• 08800247357224 - INNOVERSE Spinal System: 2025-02-24
• 08800247357231 - INNOVERSE Spinal System: 2025-02-24
• 08800247357248 - INNOVERSE Spinal System: 2025-02-24
• 08800247357255 - INNOVERSE Navigation Instruments: 2025-02-24
• 08800247357262 - INNOVERSE Navigation Instruments: 2025-02-24
• 08800247357279 - INNOVERSE Navigation Instruments: 2025-02-24
• 08800247357286 - INNOVERSE Navigation Instruments: 2025-02-24