C-QUR TACSHIELD

GUDID 00650862316360

C-QUR TACSHIELD, 8 in. X 10 in. (20.3 cm x 25.4 cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Abdominal hernia surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer Extra-gynaecological surgical mesh, composite-polymer

• Primary Device ID: 00650862316360
• NIH Device Record Key: 68ff2a36-f79d-47e0-827e-486cb383eb51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-QUR TACSHIELD
• Version Model Number: 31636
• 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	00650862316360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100076

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 TACSHIELD]

• 00650862316445: C-QUR TACSHIELD, 5 in. x 5 in. (12.5 cm x 12.5 cm)
• 00650862316384: C-QUR TACSHIELD, 6.3 in. x 12.3 in. (16 cm x 31.2 cm)
• 00650862316377: C-QUR TACSHIELD, 8 in. X 12 in. (20.3 cm x 30.5 cm)
• 00650862316360: C-QUR TACSHIELD, 8 in. X 10 in. (20.3 cm x 25.4 cm)
• 00650862316339: C-QUR TACSHIELD, 6 in. X 8 in. (15 cm x 20.3 cm)
• 00650862316285: C-QUR TACSHIELD, 4 in. X 6 in. (10 cm x 15 cm)
• 00650862316261: C-QUR TACSHIELD, 3 in. x 6 in. (7.5 cm x 15 cm)
• 00650862316124: C-QUR TACSHIELD, 10.8 in. x 13.7 in. (27.4 cm x 34.9 cm)
• 00650862316117: C-QUR TACSHIELD, 8.7 in. x 10.7 in. (22.1 cm x 27.1 cm)
• 00650862316100: C-QUR TACSHIELD, 4.5 in. x 4.5 in. (11.4 cm x 11.4 cm)