ESMARCH HEAVY BANDAGE SCISSORS

Basic Information

• Brand Name: ESMARCH HEAVY BANDAGE SCISSORS
• Primary DI: 00192896054417
• Version / Model: 1200-188
• Catalog Number: 1200-188
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-17
• Public Version: 1
• Public Version Date: 2018-10-18
• Public Version Status: New
• Public Device Record Key: f7e41bc7-1ae5-47b9-8870-580f39dc23e6

Device Description

ESMARCH HEAVY BANDAGE SCISSORS POWER CUT GOLD

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
13481	Bandage scissors, reusable	A hand-held manual instrument intended to be used to cut bandages and cloth. Typically a robust instrument, it comprises two pivoted blades provided with finger and thumb holes in the handles. The distal end of the blades may be different shapes and are usually rounded for safety; one blade may extend in front of the other and have an olive tip that is placed under the bandage. It is typically made of high-grade stainless steel and some may use carbide inserts for the cutting edge. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896054417	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	8	Inch