Mendit Retriver Universal Set ES0648

GUDID 07290019174257

The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Retriver Universal Set comprises one Retriever Cartridge, and suture passer accessory. The Retriever Cartridge operated by the Handle is used to retrieve the anchor-suture assembly after it has been placed on ligament.

ESCALA MEDICAL LTD

Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 07290019174257
• NIH Device Record Key: 069ab9cc-b12d-4c5f-b05d-0c5b2cf051de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mendit Retriver Universal Set
• Version Model Number: Mendit Retriver Universal Set
• Catalog Number: ES0648
• 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 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep away from sunlight
• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019174257 [Primary]

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

Devices Manufactured by ESCALA MEDICAL LTD

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• 07290019174257 - Mendit Retriver Universal Set: 2026-03-18The Mendit is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit Retriver Universal Set comprises one Retriever Cartridge, and suture passer accessory. The Retriever Cartridge operated by the Handle is used to retrieve the anchor-suture assembly after it has been placed on ligament.
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