UniSpace® Stand-Alone C Cage

GUDID 08800037598653

CG MedTech Co.,Ltd.

Spinal implant trial

• Primary Device ID: 08800037598653
• NIH Device Record Key: 70611e64-05a5-4246-9c8b-b6a65a76b5b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UniSpace® Stand-Alone C Cage
• Version Model Number: AUS1024
• 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	08800037598653 [Primary]

FDA Product Code

• LXH: Orthopedic manual surgical instrument

Sterilization

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

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

[08800037598653]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-30
• Device Publish Date: 2025-04-22

On-Brand Devices [UniSpace® Stand-Alone C Cage]

• 08800247357149: AU0100
• 08800247357132: AU0090
• 08800037598660: AUS1025
• 08800037598653: AUS1024
• 08800037598646: AUS1023
• 08800037598639: AUS1022
• 08800037598622: AUS1021
• 08800037598615: AUS1020
• 08800037598608: AUS1019
• 08800037598592: AUS1018
• 08800037598585: AUS1017
• 08800037598578: AUS1016
• 08800037598561: AUS1015