HERTRA 5

GUDID 18032919891799

Hertra 5 is a standard macroporous pre-shaped mesh with hole knitted with Polypropylene monofilament, indicated for the treatment of inguinal hernias, with open technique.

HERNIAMESH SRL

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

• Primary Device ID: 18032919891799
• NIH Device Record Key: c0c3197d-d20f-4744-ae80-e2a5e4806717
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERTRA 5
• Version Model Number: HTR05
• 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	18032919891799 [Unit of Use]
GS1	58032919891797 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-21
• Device Publish Date: 2021-10-13

On-Brand Devices [HERTRA 5]

• 18032919891799: Hertra 5 is a standard macroporous pre-shaped mesh with hole knitted with Polypropylene monofila
• 18032919891386: Hertra 5 cm 5,5x13 is a standard macroporous pre-shaped mesh, with hole, knitted with Polypropyl