HERTRA

GUDID 18032919891683

Hertra 9 5x11 cm is a macroporous preshaped mesh with keyhole opening, indicated for the treatment of inguinal hernia defects with open technique.

HERNIAMESH SRL

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 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 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: 18032919891683
• NIH Device Record Key: f2230d8b-b6f3-4ab8-be3a-84101e074dd0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HERTRA
• Version Model Number: HTR90511
• 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	18032919891683 [Unit of Use]
GS1	58032919891681 [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: 2023-07-24
• Device Publish Date: 2023-07-14

On-Brand Devices [HERTRA]

• 18032919892383: Hertra 9 5.5x13 cm is a macroporous preshaped mesh with keyhole opening, indicated for the treat
• 18032919891744: Hertra 9A 4.5x10 cm is a macroporous preshaped mesh without keyhole opening, indicated for the t
• 18032919891737: Hertra 9 4.5x10 cm is a macroporous preshaped mesh with keyhole opening, indicated for the trea
• 18032919891690: Hertra 9A 5x11 cm is a macroporous preshaped mesh without keyhole opening, indicated for the tre
• 18032919891683: Hertra 9 5x11 cm is a macroporous preshaped mesh with keyhole opening, indicated for the treatme
• 18032919891362: Hertra 6 cm 5,5x13 is a light macroporous pre-shaped mesh, with hole, knitted with Polypropylene