20ga ISOCLEAN™ Curved Horizontal Scissors

Basic Information

• Brand Name: 20ga ISOCLEAN™ Curved Horizontal Scissors
• Primary DI: 00840096211757
• Version / Model: VS5006-20
• Company Name: KATALYST SURGICAL LLC
• Labeler DUNS: 007883297
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-12
• Public Version: 1
• Public Version Date: 2020-06-22
• Public Version Status: New
• Public Device Record Key: 106a5d67-7323-4389-8b0f-ae33b5f8a6d4

Device Description

20ga ISOCLEAN™ Curved Horizontal Scissors

Device Characteristics

• Single Use: No
• 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: 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
HNF	Scissors, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63555	Intraocular scissors probe-tip, reusable	A distal component of a probe-like intraocular scissors assembly intended to be used to cut intraocular tissue (e.g., during anterior chamber surgery, vitrectomy). It is a probe-/cannula-like shaft with two shearing blades at the end, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). It is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840096211757	GS1