HEALICOIL

Basic Information

• Brand Name: HEALICOIL
• Primary DI: 03596010657862
• Version / Model: 72203378
• Catalog Number: 72203378
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-29
• Public Version: 9
• Public Version Date: 2023-09-20
• Public Version Status: Update
• Public Device Record Key: bd8894f1-f17d-4b67-a2fc-34c95067a871

Device Description

HEALICOIL PK 4.5 MM SUTURE ANCHOR WITH TWO ULTRABRAID No.2 SUTURES BLUE, BLUE-COBRAID STERILE

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
MBI	FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45062	Tendon/ligament bone anchor, non-bioabsorbable	A non-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 cannot be chemically degraded or absorbed via natural body processes [e.g., titanium (Ti)].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03596010657862	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113294	000
K152566	000