Mendit Bi Lateral set ES0511

GUDID 07290019174103

The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the deployment and attachment of the pre-loaded anchor- suture unit at the designated position on ligament.

ESCALA MEDICAL LTD

Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 07290019174103
• NIH Device Record Key: 63fca218-dfda-4d92-9774-10b91e5605ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mendit Bi Lateral set
• Version Model Number: Mendit Bi Lateral set - permanent suture (ePTFE 2-
• Catalog Number: ES0511
• 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

• 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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *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 *keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019174103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213783

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: 2024-06-13
• Device Publish Date: 2024-06-05

Devices Manufactured by ESCALA MEDICAL LTD

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