Silk Plus Triangle

GUDID 00643293015735

Silk Plus Triangle Size 2

TRULIFE LIMITED

External breast prosthesis

• Primary Device ID: 00643293015735
• NIH Device Record Key: 63cba75a-1fed-4586-9c73-0512ccc85219
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Silk Plus Triangle
• Version Model Number: 472 02
• Company DUNS: 985048669
• Company Name: TRULIFE LIMITED
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643293015735 [Primary]

FDA Product Code

• NOJ: PROSTHESIS, BREAST, EXTERNAL, NO ADHESIVE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-30
• Device Publish Date: 2024-07-22

Devices Manufactured by TRULIFE LIMITED

• 00645517872773 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 27CM LEFT CAT 2
• 00645517872780 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 27CM LEFT CAT 3
• 00645517872827 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 28CM LEFT CAT 1
• 00645517872834 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 28CM LEFT CAT 2
• 00645517872872 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 28CM RIGHT CAT 3
• 00645517872889 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 29CM LEFT CAT 2
• 00645517872933 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 30CM RIGHT CAT 3
• 00645517872988 - Trulife: 2025-09-29 SEATTLE SKRIDE FOOT 23CM RIGHT CAT 1 DK BRN