SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-UP

GUDID 08903837093806

HEALTHIUM MEDTECH LIMITED

Meniscus suture anchor

• Primary Device ID: 08903837093806
• NIH Device Record Key: 7dfb550b-f63f-43ba-bcfb-37d190f4ec5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SURESTITCH™ UHMWPE Suture PEEK Button Meniscus repair Implant-UP
• Version Model Number: S29-1800-TQ
• Company DUNS: 916326705
• Company Name: HEALTHIUM MEDTECH LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	08903837093806 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230891

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, Soft Tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-07
• Device Publish Date: 2024-07-30

Devices Manufactured by HEALTHIUM MEDTECH LIMITED

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• 08903837042842 - Trulon: 2025-02-24
• 08903837046260 - TRUSILK: 2025-02-24
• 08903837047328 - TRUSILK: 2025-02-24
• 08903837048677 - TRUSILK: 2025-02-24
• 08903837051455 - TRUSYNTH: 2025-02-24