PROLITE ULTRA

GUDID 20650862308017

ProLite Ultra, SFP MEDIUM W/ONLAY, 1.25in. x 2in. (3.2cm x 5cm), 4in. (10cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 20650862308017
• NIH Device Record Key: 10ee0ffc-d306-4293-a2ad-4f0b6586f981
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROLITE ULTRA
• Version Model Number: 30801
• 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	00650862308013 [Primary]
GS1	20650862308017 [Package]; Contains: 00650862308013; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002093

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 ULTRA]

• 20650862308079: ProLite Ultra SFP X-LARGE Keyhole, 1.75in. x 2in. (4.4cm x 5cm), 3.5in. (8.9cm)
• 20650862308062: ProLite Ultra, SFP LARGE KEYHOLE, 1.5in. x 2in. (3.8cm x 5cm), 3.5in. (8.9cm)
• 20650862308055: ProLite Ultra,SFP MEDIUM KEYHOLE, 1.25in. x 2in. (3.2cm x 5cm), 3.5in. (8.9cm)
• 20650862308048: ProLite Ultra, SFP SMALL KEYHOLE, 1.0in. x 2in. (2.5cm x 5cm), 3.5in. (8.9cm)
• 20650862308031: ProLite Ultra, SFP X-LARGE W/ONLAY, 1.75in. x 2in. (4.4cm x 5cm), 4in. (10cm)
• 20650862308024: ProLite Ultra, SFP LARGE W/ONLAY, 1.5in. x 2in. (3.8cm x 5cm), 4in. (10cm)
• 20650862308017: ProLite Ultra, SFP MEDIUM W/ONLAY, 1.25in. x 2in. (3.2cm x 5cm), 4in. (10cm)
• 20650862308000: ProLite Ultra, SFP Small W/ONLAY, 1.0in. x 2in. (2.5cm x 5cm), 4in. (10cm)
• 20650862307225: ProLite Ultra, 12in. x 18in. (30.5cm x 45.7cm)
• 20650862307218: ProLite Ultra, 12in. x 12in. (30.5cm x 30.5cm)
• 20650862307201: ProLite Ultra, 10in. x 14in. (25.4cm x 35.5cm)
• 20650862307195: ProLite Ultra, 10in. x 10in. (30.5cm x 30.5cm)
• 20650862307188: ProLite Ultra, 8in. x 10in. (20.3cm x 25.34cm)
• 20650862307171: ProLite Ultra, 6in. x 6in. (15cm x 15cm)
• 20650862307157: ProLite Ultra, 4in. x 6in. (10cm x 15cm)
• 20650862307140: ProLite Ultra, 3in. x 6in. (7.5cm x 15cm)
• 20650862307133: ProLite Ultra,3in. x 3in. (7.5cm x 7.5cm)
• 20650862307126: ProLite Ultra, 2in. x 12in. (5cm x 30.5cm)
• 20650862307119: ProLite Ultra, 2in. x 4in. (5cm x 10cm)
• 20650862307102: ProLite Ultra, 1in. x 4in. (2.5cm x 10cm)
• 20650862307089: ProLite Ultra, W Hole, 4in. x 5in. (10cm x 12.5cm)
• 20650862307058: ProLite Ultra, Holes & Tails, LG, 2.5in. x 5.5in. (6.4cm x 14cm)
• 20650862307041: ProLite Ultra, No Hole, Large, 2.5in. x 5.5in. (6.4cm x 14cm)
• 20650862307034: ProLite Ultra, Keyhole, Large, 2.5in. x 5in. (6.4cm x12.5cm)
• 20650862307027: ProLite Ultra, Holes and Tails SM, 2in. x 4in. (5cm x 10cm)
• 20650862307010: ProLite Ultra, No Hole, Small, 2in. x 4in. (5cm x 10cm)
• 20650862307003: ProLite Ultra, Keyhold SM, 2in. x 3.5in. (5cm x 8.9cm)