C-QUR

GUDID 00650862313284

C-QUR FX, 4 in. X 6 in. (10 cm x 15 cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 00650862313284
• NIH Device Record Key: 131561e7-ecfd-49a3-929c-7a40b20a5749
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-QUR
• Version Model Number: 31328
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00650862313284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082748

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]

• 00650862315912: C-QUR MESH, 6.25 in. x 6.25 in. (15.5 cm x 15.5 cm)
• 00650862315448: C-QUR MESH, 5 in. x 5 in. (12.5 cm x 12.5 cm)
• 00650862315431: C-QUR MESH, 3.5 in. x 3.5 in. (8.9 cm x 8.9 cm)
• 00650862315424: C-QUR MESH, 12 in. x 18 in. (30.5 cm x 45.7 cm)
• 00650862315400: C-QUR MESH, 10 in. x 14 in. (25.4 cm x 35.5 cm)
• 00650862315387: C-QUR MESH, 6.3 in. x 12.3 in. (16 cm x 31.2 cm)
• 00650862315370: C-QUR MESH, 8 in. x 12 in. (20.3 cm x 30.5 cm)
• 00650862315363: C-QUR MESH, 8 in. x 10 in. (20.3 cm x 25.4 cm)
• 00650862315356: C-QUR MESH, 7 in. x 9 in. (17.8 cm x 23 cm)
• 00650862315349: C-QUR MESH, 6 in. x 9 in. (15 cm x 23 cm)
• 00650862315332: C-QUR MESH, 6 in. x 8 in. (15 cm x 20.3 cm)
• 00650862315318: C-QUR MESH, 5.4 in. x 7 in. (13.5 cm x 17.8 cm)
• 00650862315288: C-QUR MESH, 4 in. x 6 in. (10 cm x 15 cm)
• 00650862315271: C-QUR MESH, 4.3 in. x 5.5 in. (11 cm x 14 cm)
• 00650862315264: C-QUR MESH, 3 in. x 6 in. (7.5 cm x 15 cm)
• 00650862315073: C-QUR MESH, 5.90 in. x 5.90 in. (15 cm x 15 cm)
• 00650862315066: C-QUR MESH, 5.12 in. x 5.12 in. (13 cm x 13 cm)
• 00650862315059: C-QUR MESH, 3.54 in. x 3.54 in. (9 cm x 9 cm)
• 00650862313888: C-QUR FX, 5.7 in. x 4.1 in. (14.6 cm x 10.5 cm) 3D-LAPPATCH,MED
• 00650862313857: C-QUR FX, 5.7 in. x 4.1 in. (14.6 cm x 10.5 cm) 3D-LAPPATCH, W/HOLE,MED
• 00650862313420: C-QUR FX, 12 in. x 18 in. (30.5 cm x 45.7 cm)
• 00650862313413: C-QUR FX, 12 in. X 12 in. (30.5 cm x 30.5 cm)
• 00650862313406: C-QUR FX, 10 in. X 14 in. (25.4 cm x 35.5 cm)
• 00650862313369: C-QUR FX, 8 in. X 10 in. (20.3 cm x 25.4 cm)
• 00650862313321: C-QUR FX, 6 in. X 6 in. (15 cm x 15 cm)
• 00650862313284: C-QUR FX, 4 in. X 6 in. (10 cm x 15 cm)
• 00650862313260: C-QUR FX, 3 in. X 6 in. (7.5 cm x 15 cm)
• 00650862313246: C-QUR FX, 3 in. x 3 in. (7.5 cm x 7.5 cm)
• 00650862313222: C-QUR FX, 2 in. x 4 in. (5 cm x 10 cm)
• 20650862313127: C-QUR FX, 2.5 in. x 5.5 in. (6.4 cm x 14 cm) slit & hole
• 20650862313110: C-QUR FX, 2.5 in. x 5.5 in. (6.4 cm x 14 cm) W/O slit/hole