Cerafix® Dura Substitute

GUDID 00854258006037

Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix.

ACERA SURGICAL INC

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• Primary Device ID: 00854258006037
• NIH Device Record Key: c46bf6d1-aeac-40e1-ad1a-1d3b92a99597
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cerafix® Dura Substitute
• Version Model Number: C1-3X3
• Company DUNS: 040631370
• Company Name: ACERA SURGICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch
• Width: 7.5 Centimeter
• Length: 7.5 Centimeter
• Width: 3 Inch
• Length: 3 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature. Avoid excessive heat or humidity. Do not refrigerate.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854258006037 [Primary]

FDA Product Code

• GXQ: Dura Substitute

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: 2018-03-29
• Device Publish Date: 2017-03-07

On-Brand Devices [Cerafix® Dura Substitute ]

• 00854258006051: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used
• 00854258006044: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used
• 00854258006037: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used
• 00854258006020: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used
• 00854258006013: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used
• 00854258006006: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used