ARTIA Reconstructive Tissue Matrix CM1097P

GUDID M328CM1097P0

ARTIA Reconstructive Tissue Matrix Perforated Contour Medium

LIFECELL CORPORATION

Multi-purpose surgical mesh, collagen, bioabsorbable

• Primary Device ID: M328CM1097P0
• NIH Device Record Key: 5b9fbda8-faa5-4f20-bb97-a15aad51885b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARTIA Reconstructive Tissue Matrix
• Version Model Number: CM1097P
• Catalog Number: CM1097P
• Company DUNS: 157224205
• Company Name: LIFECELL CORPORATION
• 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: true
• Serial Number: false
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -8 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818410014513 [Secondary]
HIBCC	M328CM1097P0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162752

FDA Product Code

• FTM: Mesh, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-17
• Device Publish Date: 2017-12-18

On-Brand Devices [ARTIA Reconstructive Tissue Matrix]

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• M328CXL10970: ARTIA Reconstructive Tissue Matrix Contour Extra Large
• M328CS1097P0: ARTIA Reconstructive Tissue Matrix Perforated Contour Small
• M328CS10970: ARTIA Reconstructive Tissue Matrix Contour Small
• M328CM1097P0: ARTIA Reconstructive Tissue Matrix Perforated Contour Medium
• M328CM10970: ARTIA Reconstructive Tissue Matrix Contour Medium
• M328CL1097P0: ARTIA Reconstructive Tissue Matrix Perforated Contour Large
• M328CL10970: ARTIA Reconstructive Tissue Matrix Contour Large
• M32816201097P0: ARTIA Reconstructive Tissue Matrix Perforated 16 cm X 20 cm
• M328162010970: ARTIA Reconstructive Tissue Matrix 16 cm X 20 cm
• M328101610970: ARTIA Reconstructive Tissue Matrix 10 cm x 16 cm
• M328082010970: ARTIA Reconstructive Tissue Matrix 8 cm x 20 cm
• M328081610970: ARTIA Reconstructive Tissue Matrix 8 cm x 16 cm
• M328061610970: ARTIA Reconstructive Tissue Matrix 6 cm x 16 cm