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

• 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.