PROLOOP

GUDID 20650862309038

ProLoop Mesh XL, 1.6in. x 1.8in. (4.1cm x 4.6cm), 2.0in. (5.0cm), 3.5in. (8.9cm)

ATRIUM MEDICAL CORPORATION

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 20650862309038
• NIH Device Record Key: 604a8cf8-9f65-4135-82ae-888c3695c3c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROLOOP
• Version Model Number: 30903
• 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	00650862309034 [Primary]
GS1	20650862309038 [Package]; Contains: 00650862309034; Package: [2 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 [PROLOOP]

• 20650862309236: ProLoop Mesh XL, 1.6in. x 2.0in. (4.1cm x 5.0cm)
• 20650862309229: ProLoop Mesh L, 1.6in. x 1.9in. (4.1cm x 4.8cm)
• 20650862309212: ProLoop Mesh M, 1.3in. x 1.55in. (3.3cm x 3.9cm)
• 20650862309205: ProLoop Mesh S, 1.3in. x 1.10in. (3.3cm x 2.8cm)
• 20650862309113: ProLoop Plug Mesh XL, 1.6in. x 2in. (4.1cm x 5cm), 2in. (5cm), 3.5in. (8.9cm)
• 20650862309106: ProLoop Plug Mesh L, 1.6in. x 2in. (4.1cm x 5cm), 1.9in. (4.8cm), 3.5in. (8.9cm)
• 20650862309090: ProLoop Mesh M, 1.3in. x 2in. (3.3cm x 5cm), 1.55in. (3.9cm), 3.5in. (8.9cm)
• 20650862309083: ProLoop Mesh S, 1.3in. x 2in. (3.3cm x 5cm), 1.1in. (2.8cm), 3.5in. (8.9cm)
• 20650862309038: ProLoop Mesh XL, 1.6in. x 1.8in. (4.1cm x 4.6cm), 2.0in. (5.0cm), 3.5in. (8.9cm)
• 20650862309021: ProLoop Mesh L, 1.6in. x 1.8in. (4.1cm x 4.6cm), 1.9in. (4.8cm), 3.5in. (8.9cm)
• 20650862309014: ProLoop Mesh M, 1.3in. x 1.8in. (3.3cm x 4.6cm), 1.55in. (3.9cm), 3.5in. (8.9cm)
• 20650862309007: ProLoop Mesh S, 1.3in. x 1.8in. (3.3cm x 4.6cm), 1.1in. (2.8cm), 3.5in. (8.9cm)