C-QUR V-PATCH

GUDID 00650862312027

C-QUR V-PATCH, LARGE, 3.2 in. x 3.2 in. (8.0 cm x 8.0 cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, composite-polymer

• Primary Device ID: 00650862312027
• NIH Device Record Key: 513ace3c-3b33-49b0-8c25-e8dbc6a7cd89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: C-QUR V-PATCH
• Version Model Number: 31202
• 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	00650862312027 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090909

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 V-PATCH]

• 00650862312027: C-QUR V-PATCH, LARGE, 3.2 in. x 3.2 in. (8.0 cm x 8.0 cm)
• 00650862312010: C-QUR V-PATCH, MEDIUM, 2.5 in. x 2.5 in. (6.4 cm x 6.4 cm)
• 00650862312003: C-QUR V-PATCH, SMALL, 1.7 in. x 1.7 in. (4.3 cm x 4.3 cm)