Arthrex®

Basic Information

• Brand Name: Arthrex®
• Primary DI: 00888867438255
• Version / Model: AR-7820AC
• Catalog Number: AR-7820AC
• Company Name: ARTHREX, INC.
• Labeler DUNS: 131747628
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-06-20
• Public Version: 1
• Public Version Date: 2024-06-28
• Public Version Status: New
• Public Device Record Key: 0b118971-b694-44d8-a7b6-e8d586bc889a

Device Description

AC CERCLAGE KIT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
HTN	WASHER, BOLT NUT	Orthopedic	888.3030	2
HWC	Screw, fixation, bone	Orthopedic	888.3040	2
GAT	Suture, nonabsorbable, synthetic, polyethylene	General, Plastic Surgery	878.5000	2
JDQ	Cerclage, fixation	Orthopedic	888.3010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46242	Surgical support tape, non-bioabsorbable	A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888867438255	GS1

Customer Contacts

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