C-QUR CENTRIFX

GUDID 00650862313963

C-QUR CENTRIFX, LARGE, 4.1 in. x 6.3 in. (10.5 cm x 16 cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 00650862313963
• NIH Device Record Key: b80100d9-9fd0-4537-b4ce-66cfa8cde039
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-QUR CENTRIFX
• Version Model Number: 31396
• Company DUNS: 051798999
• Company Name: ATRIUM MEDICAL CORPORATION
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00650862313963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110110

FDA Product Code

• FTL: Mesh, surgical, polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-24

On-Brand Devices [C-QUR CENTRIFX]

• 00650862313970: C-QUR CENTRIFX, X-LARGE, 4.7 in. x 6.7 in. (12 cm x 17 cm)
• 00650862313963: C-QUR CENTRIFX, LARGE, 4.1 in. x 6.3 in. (10.5 cm x 16 cm)
• 00650862313956: C-QUR CENTRIFX, MEDIUM, 3.5 in. x 5.7 in. (9 cm x 14.5 cm)