PLESTER FIRST INCISION KNIFE

Basic Information

• Brand Name: PLESTER FIRST INCISION KNIFE
• Primary DI: 00192896040236
• Version / Model: 467-463
• Catalog Number: 467-463
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-13
• Public Version: 1
• Public Version Date: 2018-10-15
• Public Version Status: New
• Public Device Record Key: 576474a0-53dd-4736-8960-25dfba5426a5

Device Description

PLESTER FIRST INCISION KNIFE

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", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYO	KNIFE, EAR	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12245	Ear knife	A hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896040236	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	6.25	Inch