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

• 00645517897776 - Trulife: 2025-09-02 PECTUS PRO, PECTUS CARINATUM ORTHOSIS
• 00645517865997 - Trulife: 2025-08-15 TRULIFE SACH WITH PYRAMID 28 R
• 00645517872230 - Trulife: 2025-08-15 TRULIFE ZUMO FOOT 27CM RIGHT
• 00645517872247 - Trulife: 2025-08-15 TRULIFE ZUMO FOOT 28CM LEFT
• 00645517872254 - Trulife: 2025-08-15 TRULIFE ZUMO FOOT 28CM RIGHT
• 00645517872261 - Trulife: 2025-08-15 TRULIFE ZUMO FOOT 29CM LEFT
• 00645517872278 - Trulife: 2025-08-15 TRULIFE ZUMO FOOT 29CM RIGHT
• 00645517872285 - Trulife: 2025-08-15 TRULIFE ZUMO FOOT 30CM LEFT