Restrata MiniMatrix

GUDID 00854258006310

Acera Surgical Inc

Synthetic wound matrix dressing

• Primary Device ID: 00854258006310
• NIH Device Record Key: 57e7e7be-140b-449c-8508-32d4081c0b51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restrata MiniMatrix
• Version Model Number: RMINI-100
• Company DUNS: 040631370
• Company Name: Acera Surgical Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• 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	00854258006310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223725

FDA Product Code

• QSZ: Absorbable Synthetic Wound Dressing

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: 2023-07-07
• Device Publish Date: 2023-06-29

On-Brand Devices [Restrata MiniMatrix]

• 00854258006358: RMINI-2000
• 00854258006341: RMINI-1000
• 00854258006334: RMINI-500
• 00854258006327: RMINI-250
• 00854258006310: RMINI-100