N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885825014100
• Version / Model: N/A
• Catalog Number: ASC1335-01
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Labeler DUNS: 020198912
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2020-02-14
• Public Version Status: Update
• Public Device Record Key: 45722eaf-2f67-499b-a89d-8727bc5833fd

Device Description

Soft Tissue Ablator 90 w/Integrated Cable

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
NUJ	ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61951	Endoscopic electrosurgical electrode, bipolar, reprocessed	A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a bipolar configuration (i.e., without a return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps) which may include a lumen for suction/irrigation; it does not include a handpiece/housing with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). 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	30885825014101	GS1	pack	4	In Commercial Distribution
Primary	00885825014100	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K043198	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Degree: 90.0 Degree

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 25 Degrees Celsius