InnovaMatrix AC IMX-15MM-01

GUDID 00850002643145

15mm Disc Placental ECM

Triad Life Sciences, Inc.

Wound compression dressing

• Primary Device ID: 00850002643145
• NIH Device Record Key: ffe88760-028c-4fcb-819b-0b200cc8198d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnovaMatrix AC
• Version Model Number: IMX-15MM-01
• Catalog Number: IMX-15MM-01
• Company DUNS: 081037338
• Company Name: Triad Life Sciences, Inc.
• 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	00850002643145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193552

FDA Product Code

• KGN: Dressing, Wound, Collagen

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: 2022-01-05
• Device Publish Date: 2021-12-28

On-Brand Devices [InnovaMatrix AC]

• 00850002643183: 4cm x 6xm Placental ECM
• 00850002643176: 5cm x 5cm Placental ECM
• 00850002643169: 4cm x 4cm Placental ECM
• 00850002643152: 2cm x 2cm Placental ECM
• 00850002643145: 15mm Disc Placental ECM
• 00850002643435: 3cm x 4cm Porcine Placenta Derived ECM
• 00850002643428: 2cm x 3cm Porcine Placenta Derived ECM
• 00850002643411: 18 mm Disc Porcine Placenta Derived ECM