ROUND PATCH

GUDID 58032919890783

Round patch 10 cm is a round rigid mesh knitted with Polypropylene monofilament, indicated for open pre-peritoneal umbilical hernia repairs; no sutur

HERNIAMESH SRL

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 58032919890783
• NIH Device Record Key: ca7fa8ab-87e2-4915-b8f0-81cc3c1aa0be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROUND PATCH
• Version Model Number: HT1C10
• Company DUNS: 459310140
• Company Name: HERNIAMESH SRL
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	18032919890785 [Unit of Use]
GS1	58032919890783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K973955

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: 2016-08-02

On-Brand Devices [ROUND PATCH]

• 58032919890783: Round patch 10 cm is a round rigid mesh knitted with Polypropylene monofilament, indicated for
• 18032919891256: Round patch diameter 10 cm is a round macroporous mesh knitted with Polypropylene monofilament,