NA

Basic Information

• Brand Name: NA
• Primary DI: 10888551019002
• Version / Model: ETHHC105
• Catalog Number: ETHHC105
• Company Name: STERILMED, INC.
• Labeler DUNS: 175899459
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 6
• Public Version Date: 2019-09-10
• Public Version Status: Update
• Public Device Record Key: 30c0e958-9b11-4acc-947c-96d45e8b40a7
• Distribution End Date: 2019-04-17

Device Description

HARMONIC SCALPEL BLADE CURVED

Device Characteristics

• Single Use: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NLQ	Scalpel, ultrasonic, reprocessed	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
61845	Soft-tissue ultrasonic surgical system holder/tip, reprocessed	A hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, and is typically made of metal. This device is utilized in a variety of surgical disciplines. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10888551019002	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K012571	000