Restrata(R)

GUDID 00854258006129

Restrata(R) is a sterile, single use device intended for use in local management of wounds. Restrata(R) is a soft, white, conformable, non-friable, absorbable matrix that provides an environment for the body’s natural healing process to occur.

ACERA SURGICAL INC

Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing Bioabsorbable wound dressing

• Primary Device ID: 00854258006129
• NIH Device Record Key: a36f6aac-4c47-44fb-9da9-ecd7afa5de8b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Restrata(R)
• Version Model Number: RWM1-1X2
• 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 Dimensions

• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter
• Length: 5 Centimeter
• Width: 2.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854258006129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170300

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-11
• Device Publish Date: 2019-05-20

Devices Manufactured by ACERA SURGICAL INC

• 00854258006310 - Restrata MiniMatrix: 2023-07-07
• 00854258006327 - Restrata MiniMatrix: 2023-07-07
• 00854258006334 - Restrata MiniMatrix: 2023-07-07
• 00854258006341 - Restrata MiniMatrix: 2023-07-07
• 00854258006358 - Restrata MiniMatrix: 2023-07-07
• 00854258006105 - Restrata Wound Matrix: 2022-04-29 The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
• 00854258006242 - Restrata Wound Matrix: 2022-04-29 The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.
• 00854258006259 - Restrata Wound Matrix: 2022-04-29 The Restrata Wound Matrix is a sterile, single use device intended for use in local management of wounds.