APYX Retriever Set

Basic Information

• Brand Name: APYX Retriever Set
• Primary DI: 07290019174011
• Version / Model: Apyx Retriever Set Resorbable Suture
• Catalog Number: ES0149
• Company Name: ESCALA MEDICAL LTD
• Labeler DUNS: 600469711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-06
• Public Version: 1
• Public Version Date: 2022-11-14
• Public Version Status: New
• Public Device Record Key: 5922b5ff-44b3-4fc7-9922-234465fc6d6c

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PBQ	Fixation, Non-Absorbable Or Absorbable, For Pelvic Use	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45027	Soft-tissue/mesh anchor, bioabsorbable	A bioabsorbable device designed to be implanted into ligaments or other soft tissues for soft-tissue approximation and/or to serve as a site of attachment for surgical mesh or sutures; it is not intended to anchor soft tissues to bone, nor repair cartilage, and is not intended for ophthalmic use. It is available in a variety of designs (e.g., screw-, punch-, staple-like) and is made of a polymer that can be chemically degraded via natural body processes. It is intended to create a fixed anchor point and is not a suture-based fastening device such as a T-fastener. It is typically implanted with the use of a specialized applicator which may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290019174011	GS1

Premarket Submissions

Submission Number	Supplement Number
K213783	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -10 – 40 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: keep away from sunlight