Dubois Twistripper (set)

Basic Information

• Brand Name: Dubois Twistripper (set)
• Primary DI: 20697660005700
• Version / Model: A1-350
• Company Name: Oculo-Plastik Inc
• Labeler DUNS: 257382580
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-28
• Public Version: 2
• Public Version Date: 2022-03-25
• Public Version Status: Update
• Public Device Record Key: 5d584fb4-3e86-4345-aa21-818bc5d9aaff
• Distribution End Date: 2022-03-24

Device Description

Surgical instruments for varicose extraction (200 & 300 mm)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
GAI	Stripper, Vein, Reusable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35377	Vein stripper, reusable	A hand-held surgical instrument designed to manually excise (strip by stab avulsion) a length or section of a vein from a patient, typically varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is typically designed as: 1) a flexible stainless steel cable with a stripping cup or disk (commonly known as an olive) attached to one end, and a handle at the other (some types can employ a guide tip); or 2) a rigid or semi-rigid rod terminating in a closed ring or loop (also known as a ring stripper). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20697660005700	GS1

Customer Contacts

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