Trulene Mesh

GUDID 08903837067388

HEALTHIUM MEDTECH LIMITED

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 08903837067388
• NIH Device Record Key: e8088e6b-af87-4bd2-8cf7-50bf2d06ab5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trulene Mesh
• Version Model Number: TVM611
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08903837067388 [Primary]

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2025-08-18
• Device Publish Date: 2024-07-11

On-Brand Devices [Trulene Mesh]

• 08903837067203: TVLM303
• 08903837105042: TVLM151
• 08903837067401: TVM715
• 08903837067388: TVM611
• 08903837067340: TVM303
• 08903837067326: TVM151
• 08903837067036: TMM715
• 08903837066978: TMM151