HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD

Basic Information

• Brand Name: HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD
• Primary DI: 10886705030835
• Version / Model: 222455
• Catalog Number: 222455
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-11
• Public Version: 1
• Public Version Date: 2019-07-19
• Public Version Status: New
• Public Device Record Key: 01abde3f-5d82-472f-88d7-799df81e5183

Device Description

HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blue PERMATAPE Braided Flat Suture, 38" (96 cm) and (1) Blue, Size 2 (5 metric) DYNACORD Braided Suture, 36" (91cm), (1) Utility Shuttle Suture 4.5mm

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
Primary	10886705030835	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K191483	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 77 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 0 – 77 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 0 – 25 Degrees Celsius