Restrata MiniMatrix

GUDID 00854258006358

Acera Surgical Inc

Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing Synthetic wound matrix dressing

• Primary Device ID: 00854258006358
• NIH Device Record Key: 44d8fd45-2ac1-4fe5-98b4-531c66712d78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restrata MiniMatrix
• Version Model Number: RMINI-2000
• 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	00854258006358 [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