Trulene

GUDID 08903837227355

HEALTHIUM MEDTECH LIMITED

Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 08903837227355
• NIH Device Record Key: 6aa76bbd-5566-419b-9b64-209196049651
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trulene
• Version Model Number: 8E75AX60
• 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	08903837227355 [Primary]

FDA Product Code

• GAW: Suture, Nonabsorbable, Synthetic, Polypropylene

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: 2025-02-24
• Device Publish Date: 2025-02-16

On-Brand Devices [Trulene]

• 08903837037787: 8I45CX11
• 08903837243270: 8H45CX13
• 08903837280466: 8F75AX60
• 08903837264930: 8G75CX19P
• 08903837227355: 8E75AX60
• 08903837033284: 8D100DZ40