FILAXYN

Basic Information

• Brand Name: FILAXYN
• Primary DI: 18904255216355
• Version / Model: PDX10358Y
• Catalog Number: PDX10358Y
• Company Name: MERIL ENDO SURGERY PRIVATE LIMITED
• Labeler DUNS: 870914838
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 24
• Record Status: Published
• Publish Date: 2018-10-05
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: c7a37d76-966d-4c31-9543-b3bc8d3c5c74

Device Description

Monofilament poly (p-dioxanone) Surgical Suture

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 Safe
• 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
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	878.4840	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16584	Polyester suture, bioabsorbable, monofilament, non-antimicrobial	A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18904255216355	GS1
Unit of Use	08904255216358	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K172659	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store below 25 °C