CovoraTM

GUDID 00854258006211

CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is a soft, 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: 00854258006211
• NIH Device Record Key: dfd5e39a-345e-4d38-b03f-70d24528cfdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CovoraTM
• Version Model Number: COV1-7.5X7.5
• 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

• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854258006211 [Primary]

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: 2019-10-04

On-Brand Devices [CovoraTM]

• 00854258006228: CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is
• 00854258006211: CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is
• 00854258006204: CovoraTM is a sterile,single use device intended for use in partial thickness burns. CovoraTM is