HEALIX ADVANCE ORTHOCORD

Basic Information

• Brand Name: HEALIX ADVANCE ORTHOCORD
• Primary DI: 10886705021529
• Version / Model: 222324
• Catalog Number: 222324
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 6
• Public Version Date: 2023-12-22
• Public Version Status: Update
• Public Device Record Key: 9da8e30d-9327-4179-9266-e3f8728b6c86

Device Description

HEALIX ADVANCE BR MULTIPACK - 3 SUTURE (5) TCP/PLGA Absorbable Anchors, Each Anchor contains (1) Violet (1) Blue Strand (1) Blue Striped, Size 2 (5 Metric) ORTHOCORD Braided Composite Suture, 36 Inches (91cm) 5.5mm

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
MAI	FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45061	Tendon/ligament bone anchor, bioabsorbable	A bioabsorbable device designed to be implanted into bone for the attachment of tendons/ligaments/soft tissues either directly or via a suture attached to the device; typically used in arthroscopic or open surgical procedures. This device is available in various designs and sizes and is made of a material that can be chemically degraded and typically absorbed via natural body processes (e.g., a copolymer, metal alloy).	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20886705021526	GS1	PACKAGE	5	In Commercial Distribution
Primary	10886705021529	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: High: 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: High: 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius