ACHILLON®

Basic Information

• Brand Name: ACHILLON®
• Primary DI: 10381780043300
• Version / Model: 119720ND
• Catalog Number: 119720ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2017-10-05
• Public Version: 6
• Public Version Date: 2023-02-06
• Public Version Status: Update
• Public Device Record Key: a256f998-558b-4dd3-ac63-607cf57066b4
• Distribution End Date: 2027-03-14

Device Description

The needle for the Achillon® suture system is used to suture the Achilles tendon parts in acute Achilles tendon rupture.

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HCF	INSTRUMENT, LIGATURE PASSING AND KNOT TYING	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61143	Suturing needle, single-use	A cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248119720ND1	HIBCC
Primary	10381780043300	GS1
Unit of Use	00381780043303	GS1

Customer Contacts

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