HEAVY SYNTHETIC CAST SHEARS

Basic Information

• Brand Name: HEAVY SYNTHETIC CAST SHEARS
• Primary DI: 00192896026889
• Version / Model: 240-614
• Catalog Number: 240-614
• 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: b397d86f-3eb1-42ca-8a1a-d8a3e54f98c4

Device Description

HEAVY SYNTHETIC CAST SHEARS TUNGSTEN CARBIDE BLUNT TIP

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
LRW	SCISSORS, GENERAL, SURGICAL	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16341	Cast cutting shears	A large, scissors-like, hand-held instrument whose blades distal to the pivot point terminate in various jaw configurations, capable of cutting heavy layers of plaster or synthetic material used to form hardened casts, i.e., that which has already been used to form a cast around a patient's limb or body part. The tip of one of the distal blades forming the scissors-like cutting mechanism is usually rounded along it bottom edge to prevent injury to the patient as the cast is cut. This device is typically made of high-grade stainless steel and will usually be provided with a spring mechanism to assist in opening the jaws. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896026889	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	9	Inch