ANAX™ 5.5 Spinal System

GUDID 08800037597977

CG MedTech Co.,Ltd.

Bone tap, reusable

• Primary Device ID: 08800037597977
• NIH Device Record Key: ca0bad3d-851e-4fdd-920b-50b0135c3a1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANAX™ 5.5 Spinal System
• Version Model Number: SF0060
• 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	08800037597977 [Primary]

FDA Product Code

• HWX: TAP, BONE

Sterilization

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

[08800037597977]

Moist Heat or Steam Sterilization

[08800037597977]

Moist Heat or Steam Sterilization

[08800037597977]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

On-Brand Devices [ANAX™ 5.5 Spinal System]

• 08800037597991: SF0080
• 08800037597984: SF0070
• 08800037597977: SF0060
• 08800037597960: SF0050
• 08800037597953: SF0040