C-QUR MOSAIC

GUDID 00650862311389

C-QUR Mosaic, 6.3in x 12.3in, (16 cm x 31.2 cm) Oval

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 00650862311389
• NIH Device Record Key: 8040a2e8-2a20-42b4-aa0e-631bfd6875b9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-QUR MOSAIC
• Version Model Number: 31138
• 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	00650862311389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121070

FDA Product Code

• OXA: Mesh, surgical, non-absorbable, thoracic, chest wall reconstruction

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 MOSAIC]

• 00650862311440: C-QUR Mosaic, 5in x 5in, (12.5 cm x 12.5 cm)
• 00650862311433: C-QUR Mosaic, 3.5in x 3.5in, (8.9 cm x 8.9 cm)
• 00650862311426: C-QUR Mosaic, 12in x 18in, (30.5 cm x 45.7 cm)
• 00650862311402: C-QUR Mosaic, 10in x 14in, (25.4 cm x 35.5 cm)
• 00650862311389: C-QUR Mosaic, 6.3in x 12.3in, (16 cm x 31.2 cm) Oval
• 00650862311372: C-QUR Mosaic, 8in x 12in, (20.3 cm x 30.5 cm)
• 00650862311365: C-QUR Mosaic, 8in x 10in, (20.3 cm x 25.4 cm)
• 00650862311358: C-QUR Mosaic, 7in x 9in, (17.8 cm x 23 cm)
• 00650862311341: C-QUR Mosaic, 6in x 9in, (15 cm x 23 cm)
• 00650862311334: C-QUR Mosaic, 6in x 8in, (15 cm x 20.3 cm)
• 00650862311310: C-QUR Mosaic, 5.4in x 7in, (13.5 cm x 17.8 cm)
• 00650862311280: C-QUR Mosaic, 4in x 6in, (10 cm x 15 cm)
• 00650862311273: C-QUR Mosaic, 4.3in x 5.5in, (11 cm x 14 cm)
• 00650862311266: C-QUR Mosaic, 3in x 6in, (7.5 cm x 15 cm)
• 00650862311075: C-QUR Mosaic, 5.90in (15 cm) Round
• 00650862311068: C-QUR Mosaic, 5.12in (13 cm) Round
• 00650862311051: C-QUR Mosaic, 3.54in (9 cm) Round