HERTRA KIT

GUDID 18032919890259

Kit #3 includes a semirigid pre-shaped mesh with hole knitted with Polypropylene monofilament and a tridimensional plug with a round base.The base is made of macroporous mesh, the tip is made of rigid mesh, both knitted with Polypropylene monofilament.

HERNIAMESH SRL

Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 18032919890259
• NIH Device Record Key: 63ff93a2-dade-4bc2-b822-7895db82d63f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERTRA KIT
• Version Model Number: H2T25
• Company DUNS: 459310140
• Company Name: HERNIAMESH SRL
• Device Count: 1
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032919890259 [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: 2024-04-02
• Device Publish Date: 2024-03-25

On-Brand Devices [HERTRA KIT]

• 18032919890129: Kit #2 includes a macroporous rigid preshaped mesh with keyhole opening and a three-dimensional
• 18032919890112: Kit #1 includes a macroporous rigid preshaped mesh with keyhole opening and a three-dimensional
• 18032919890259: Kit #3 includes a semirigid pre-shaped mesh with hole knitted with Polypropylene monofilament an