T-SLING

GUDID 28032919892120

The code 5194001400, brand name “T-Sling” where T stands for tension-free, is a medical device entirely made in Polypropylene monofilament used for th

HERNIAMESH SRL

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Abdominal hernia 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 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: 28032919892120
• NIH Device Record Key: b2c7c6f7-2e15-4e7c-b66b-32c730b84b4c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T-SLING
• Version Model Number: 5194001400
• Company DUNS: 459310140
• Company Name: HERNIAMESH SRL
• Device Count: 2
• 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	18032919892123 [Unit of Use]
GS1	28032919892120 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020652

FDA Product Code

• PAH: Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

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: 2016-08-05

Devices Manufactured by HERNIAMESH SRL

• 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
• 18032919891362 - HERTRA: 2024-04-02 Hertra 6 cm 5,5x13 is a light macroporous pre-shaped mesh, with hole, knitted with Polypropylene monofilament, indicated for the
• 18032919890112 - HERTRA KIT: 2023-07-24 Kit #1 includes a macroporous rigid preshaped mesh with keyhole opening and a three-dimensional plug on a macroporous round base
• 18032919890129 - HERTRA KIT: 2023-07-24 Kit #2 includes a macroporous rigid preshaped mesh with keyhole opening and a three-dimensional plug on a macroporous round base
• 18032919891881 - PLUG T2: 2023-07-24 Plug T2 5 cm is a macroporous three-dimensional plug on a round base, indicated for treatment of inguinal and femoral hernia def
• 18032919891898 - PLUG T2: 2023-07-24 Plug T2 7 cm is a macroporous three-dimensional plug on a round base, indicated for treatment of inguinal and femoral hernia def
• 18032919891874 - PLUG T2: 2023-07-24 Plug T2 3 cm is a macroporous three-dimensional plug on a round base, indicated for treatment of inguinal and femoral hernia def
• 18032919891683 - HERTRA: 2023-07-24 Hertra 9 5x11 cm is a macroporous preshaped mesh with keyhole opening, indicated for the treatment of inguinal hernia defects wi