Mendit Single Applicator Set ES0647

GUDID 07290019174431

The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Single ApplicatorSet comprises one Applicator Cartridge, with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Mendit is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.

ESCALA MEDICAL LTD

Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 07290019174431
• NIH Device Record Key: 79ea722a-96b4-496a-b862-f57c31ce1cc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mendit Single Applicator Set
• Version Model Number: Mendit Single Applicator Set - Resorbable suture
• Catalog Number: ES0647
• Company DUNS: 600469711
• Company Name: ESCALA MEDICAL LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Specify: keep away from sunlight
• Handling Environment Temperature: Between -10 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019174431 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230730

FDA Product Code

• PBQ: Fixation, Non-Absorbable Or Absorbable, For Pelvic Use

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: 2026-03-18
• Device Publish Date: 2026-03-10

On-Brand Devices [Mendit Single Applicator Set]

• 07290019174448: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the
• 07290019174431: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the
• 07290019174240: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the
• 07290019174233: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the
• 07290019174226: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the
• 07290019174219: The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the