KAYE BLEPHAROPLASTY SCISSORS

Basic Information

• Brand Name: KAYE BLEPHAROPLASTY SCISSORS
• Primary DI: 00192896014916
• Version / Model: 13-6810
• Catalog Number: 13-6810
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-12
• Public Version: 2
• Public Version Date: 2023-04-03
• Public Version Status: Update
• Public Device Record Key: 509747ac-2ada-4f2a-be51-732053f3e24d

Device Description

KAYE BLEPHAROPLASTY SCISSORS CURVED SERRATED BLADE POWER CUT SILVER RIBBON HANDLE

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: ["Dry Heat Sterilization", "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
63480	Blepharoplasty scissors	A hand-held, manual, ophthalmic surgical instrument intended to be used to cut eyelid tissue during plastic surgery of the eyelids (blepharoplasty). It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes. It is not intended for intraocular surgery. 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	00192896014916	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4.25	Inch