PROLITE

GUDID 20650862302015

ProLite Mesh, 2in. x 3.5in. (5cm x 8.9cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 20650862302015
• NIH Device Record Key: b12700e6-4560-4f01-a6b8-72c73aca58f1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROLITE
• Version Model Number: 1010204-02
• 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	00650862302011 [Primary]
GS1	20650862302015 [Package]; Contains: 00650862302011; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151437

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: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2015-09-24

On-Brand Devices [PROLITE]

• 20650862305092: ProLite Mesh L, 1.5in. x 2.5in. (3.8cm x 6.4cm), 5in. (12.5cm)
• 20650862302114: ProLite Mesh, 4in. x 5in. (10cm x 12.5cm)
• 20650862302107: ProLite Mesh, 4in. x 5in. (10cm x 12.5cm)
• 20650862302084: ProLite Mesh, 2.5in. x 5.5in. (6.4cm x 14cm)
• 20650862302077: ProLite Mesh, 2.5in. x 5.5in. (6.4cm x 14cm)
• 20650862302060: ProLite Mesh, 2.5in. x 5in. (6.4cm x 12.5cm)
• 20650862302053: ProLite Mesh, 2in. x 4in. (5cm x 10cm)
• 20650862302046: ProLite Mesh, 2in. x 4in. (5cm x 10cm)
• 20650862302015: ProLite Mesh, 2in. x 3.5in. (5cm x 8.9cm)
• 20650862301605: ProLite Mesh M, 1.25in. x 2in. (3.2cm x 5cm), 3.5in. (8.9cm)
• 20650862301599: ProLite Mesh S, 1.0in. x 2in. (2.5cm x 5cm), 3.5in. (8.9cm)
• 20650862301124: ProLite Mesh XL, 1.75in. x 2in. (4.4cm x 5 cm), 3.5in. (8.9cm)
• 20650862301117: ProLite Mesh L, 1.5in. x 2in. (3.8cm x 5cm), 3.5in. (8.9cm)
• 20650862301063: ProLite Mesh XL, 1.75in. x 2in. (4.4cm x 5 cm), 3.5in. (8.9cm)
• 20650862301032: ProLite Mesh L, 1.5in. x 2in. (3.8cm x 5cm), 4in. (10cm)
• 20650862301025: ProLite Mesh M, 1.25in. x 2in. (3.2cm x 5cm), 4in. (10cm)
• 20650862301018: ProLite Mesh S, 1.0in. x 2in. (2.5cm x 5cm), 4in. (10cm)
• 20650862300257: ProLite Mesh, 0.7in. x 3in. (1.8cm x 7.5cm)
• 20650862300240: ProLite Mesh, 6in. x 9in. (15cm x 23cm)
• 20650862300233: ProLite Mesh, 1.8in. x 3.5in. (4.6cm x 8.9cm)
• 20650862300202: ProLite Mesh, 4in. x 7in. (10cm x 17.8cm)
• 20650862300127: ProLite Mesh, 12in. x 18in. (30.5cm x 45.7cm)
• 20650862300103: ProLite Mesh, 12in. x 12in. (30.5cm x 30.5cm)
• 20650862300097: ProLite Mesh, 10in. x 14in. (25.4cm x 35.5cm)
• 20650862300073: ProLite Mesh, 6" x 6" (15cm x 15cm)
• 20650862300066: ProLite Mesh, 4in. x 6in. (10cm x 15cm)
• 20650862300059: ProLite Mesh, 3in. x 6in. (7.5cm x 15cm)
• 20650862300042: ProLite Mesh, 3in. x 3in. (7.5cm x 7.5cm)
• 20650862300035: ProLite Mesh, 2in. x 12in. (5cm x 30.5cm)
• 20650862300028: ProLite Mesh, 2in. x 4in. (5cm x 10cm)
• 20650862300011: ProLite Mesh, 1in. x 4in. (2.5cm x 10cm)