Spetzler-Malis

Basic Information

• Brand Name: Spetzler-Malis
• Primary DI: 07613327300192
• Version / Model: 6760-180-005
• Catalog Number: 6760-180-005
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-01-03
• Public Version: 5
• Public Version Date: 2019-11-22
• Public Version Status: Update
• Public Device Record Key: 25179b20-aab9-4d0b-b912-398f4297beb2

Device Description

Disposable Standard Bipolar Forceps, Non-Stick,

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56296	Open-surgery electrosurgical handpiece/electrode, bipolar, single-use	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 single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327300193	GS1	pack	5	In Commercial Distribution
Primary	07613327300192	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	18.0	Centimeter
Device Size Text, specify			Diameter: 0.5 Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 10 – 38 Degrees Celsius