Mendit Bi-Lateral Set ES0516

GUDID 07290019174110

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: 07290019174110
• NIH Device Record Key: 6d92a7e7-416a-4f24-a9c4-9cc739385896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mendit Bi-Lateral Set
• Version Model Number: Mendit Bi-Lateral Set - permanent suture (ePTFE U
• Catalog Number: ES0516
• 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	07290019174110 [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

• 07290019174097 - Mendit applicator set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174103 - Mendit Bi Lateral set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174110 - Mendit Bi-Lateral Set: 2024-06-13The 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.
• 07290019174110 - Mendit Bi-Lateral Set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174127 - Mendit Applicator Set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174134 - Mendit Applicator Set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174141 - Mendit Bi-Lateral Set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174158 - Mendit Applicator Set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl
• 07290019174165 - Mendit Bi-Lateral Set: 2024-06-13 The Applicator comprises of the Applicator Cartridge and Handle. Upon insertion and guidance to the ligament it enables the depl