Trulene Mesh

GUDID 08903837067203

HEALTHIUM MEDTECH LIMITED

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial

• Primary Device ID: 08903837067203
• NIH Device Record Key: 78fd1cbb-0822-4c54-82bf-df47173446e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trulene Mesh
• Version Model Number: TVLM303
• Company DUNS: 916326705
• Company Name: HEALTHIUM MEDTECH LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	08903837067203 [Primary]

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

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: 2022-04-26
• Device Publish Date: 2022-04-18

Devices Manufactured by HEALTHIUM MEDTECH LIMITED

• 08903837019646 - PD Synth: 2025-02-24
• 08903837020048 - PD Synth: 2025-02-24
• 08903837033284 - Trulene: 2025-02-24
• 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