Bi-Lateral Applicator Set

Basic Information

• Brand Name: Bi-Lateral Applicator Set
• Primary DI: 07290019174028
• Version / Model: Bi-Lateral Applicator Set– resorbable suture
• Catalog Number: ES0321
• Company Name: ESCALA MEDICAL LTD
• Labeler DUNS: 600469711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-25
• Public Version: 1
• Public Version Date: 2023-07-03
• Public Version Status: New
• Public Device Record Key: 1da9436b-d86a-4f59-b3d3-681220825e70

Device Description

The Apyx is a single-use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Apyx device Bi-Lateral Set comprises the following elements: Applicator – a delivery system comprising two Applicator Cartridge, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge). The Apyx is a disposable device supplied sterile, pre-loaded with the anchor-suture unit, and ready for use.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Methods: Ethylene Oxide

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	07290019174028	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