N/A

Basic Information

• Brand Name: N/A
• Primary DI: 07613327417845
• Version / Model: LF4418
• Catalog Number: LF4418
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Labeler DUNS: 020198912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-24
• Public Version: 3
• Public Version Date: 2018-08-21
• Public Version Status: Update
• Public Device Record Key: f4d6dda1-26c2-40d0-ada6-bffb5fce646e

Device Description

Open Surgery Sealer/Divider 36mm-18cm length

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NUJ	ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61818	Open-surgery electrosurgical handpiece/electrode, bipolar, reprocessed	A sterile rigid combined electrosurgical handpiece and bipolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation during an open surgical procedure. It is available in a variety of forms (e.g., pen, pistol-shaped forceps, pincer-shaped forceps, scissors) and may also include irrigation, aspiration, lavage and/or surgical plume (smoke) evacuation features to support its primary electrosurgical function. 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
Package	57613327417840	GS1	case	6	In Commercial Distribution
Primary	07613327417845	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180451	000

Device Sizes

Type	Value	Unit	Text
Length	18.0	Centimeter
Device Size Text, specify			Diameter: 13.5 Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 15 – 90 Percent (%) Relative Humidity