ORTHOCORD

Basic Information

• Brand Name: ORTHOCORD
• Primary DI: 10886705008605
• Version / Model: 222982
• Catalog Number: 222982
• Company Name: DEPUY MITEK, LLC
• Labeler DUNS: 190572854
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 4
• Public Version Date: 2019-03-21
• Public Version Status: Update
• Public Device Record Key: 356c732e-357a-4384-9d00-e75921cfc384

Device Description

RC Loop (DS) Anchor w / ORTHOCORD With two Number 2 (5 metric) ORTHOCORD Braided Composite Sutures, 36 Inches (91cm), Violet and Blue, each armed with 2 MO-7 Tapered needles. Size 2 (5 metric) ORTHOCORD eyelet loop.

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: Yes
• 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
JDR	STAPLE, FIXATION, BONE	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	10886705008605	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: High: 80 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: High: 26 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: High: 80 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: High: 26 Degrees Celsius