APYX Retriever Set ES0149

GUDID 07290019174011

The Retriever is an accessory tool allowing the retrieval of the Anchor-Suture implant from the deployment site during the index procedure. Its use is optional, and intended only in cases when retrieval of the implant is deemed necessary by the operating surgeon due to a sub-optimal placement. Using the Retriever is possible once the implant has been deployed, and before the attached suture tails are cut. Retrieving an implant does not require making an incision in the tissue or the ligament it was introduced to.

ESCALA MEDICAL LTD

Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable Soft-tissue/mesh anchor, bioabsorbable

• Primary Device ID: 07290019174011
• NIH Device Record Key: 5922b5ff-44b3-4fc7-9922-234465fc6d6c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APYX Retriever Set
• Version Model Number: Apyx Retriever Set Resorbable Suture
• Catalog Number: ES0149
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019174011 [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: 2022-11-14
• Device Publish Date: 2022-11-06

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: 2024-06-13 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