Mendit Bi-Lateral Applicator Set

Basic Information

• Brand Name: Mendit Bi-Lateral Applicator Set
• Primary DI: 07290019174424
• Version / Model: Mendit Bi-Lateral Applicator Set Resorbable Suture
• Catalog Number: ES0172
• Company Name: ESCALA MEDICAL LTD
• Labeler DUNS: 600469711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-23
• Public Version: 1
• Public Version Date: 2023-10-31
• Public Version Status: New
• Public Device Record Key: 7dc9e74e-4ef8-4ec1-8557-fd30959a32cb

Device Description

The Mendit is a single use repair system which enables anchoring of sutures to ligaments of the pelvic floor. The Mendit device Bi-Lateral Set comprises the following elements: Applicator – a delivery system comprising two Applicator Cartridges, each with an Anchor-Suture unit (pre-loaded in the Applicator Cartridge) and Securement Elements for optional use. The Mendit 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): 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	07290019174424	GS1

Storage Conditions

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