TWISTR

Basic Information

• Brand Name: TWISTR
• Primary DI: 10886705026173
• Version / Model: 232301
• Catalog Number: 232301
• Company Name: Medos International Sàrl
• Labeler DUNS: 482661753
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-15
• Public Version: 5
• Public Version Date: 2021-08-30
• Public Version Status: Update
• Public Device Record Key: c8717684-2a2e-4e51-9170-64b216f4001f

Device Description

TWISTR Outside-In ACL Disposables Kit Kit Contains: TWISTR Outside-In Suture Passing Fork, 1.1mm x 15 Inches (38 cm) Nitinol Guidewire, 14 Inches Drill Tip Passing Pin (2.4mm x 35 cm), Malleable Graft Retractor, Marking Pen, Ruler (0-15cm Plus or Minus 0.5mm)

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: 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: 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
KDD	Kit, surgical instrument, disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64145	Ligament reconstruction instrument set, single-use	A collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10886705026173	GS1

Customer Contacts

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