RELIMESH

GUDID 18032919891560

Relimesh cm 14x18 oval is a composite prosthetic comprised of Polypropylene and expanded Polytetrafluoroethylene (ePTFE).

HERNIAMESH SRL

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: 18032919891560
• NIH Device Record Key: f13e2ece-6f6a-4c57-91dd-869e634bbfe4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RELIMESH
• Version Model Number: PEP1418-O
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18032919891560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081327

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: 2016-08-12

Devices Manufactured by HERNIAMESH SRL

• 18032919891072 - PLUG T2: 2025-08-18 Plug T2 5 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and
• 18032919891089 - PLUG T2: 2025-08-18 Plug T2 7 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and
• 18032919891065 - PLUG T2: 2025-08-18 Plug T2 3 cm is a three-dimensional plug on a macroporous round base with rigid tip, indicated for the treatment of inguinal and
• 18032919891041 - PLUG T1: 2025-08-18 Plug T1 5 cm is a macroporous round preshaped flat plug, indicated for the treatment of inguinal hernia defect with open techniq
• 18032919891058 - PLUG T1: 2025-08-18 Plug T1 7 cm is a macroporous round preshaped flat plug, indicated for the treatment of inguinal hernia defect with open techniq
• 18032919891171 - PLUG T4: 2025-08-18 PLUG T4 is a semi-rigid round macroporous preshaped mesh with an eccentric keyhole, indicated for the treatment of inguinal hern
• 18032919891829 - PLUG T4: 2025-08-18 PLUG T4 is a standard macroporous mesh, knitted with quadriaxial technology, round shaped with an eccentric keyhole, indicated f
• 18032919890259 - HERTRA KIT: 2024-04-02 Kit #3 includes a semirigid pre-shaped mesh with hole knitted with Polypropylene monofilament and a tridimensional plug with a r