AED-SLT STRYKER SMALL JOINT-STOP

Basic Information

• Brand Name: AED-SLT STRYKER SMALL JOINT-STOP
• Primary DI: 00848657074940
• Version / Model: SLT-STK SMJ
• Catalog Number: SLT-STK SMJ
• Company Name: NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
• Labeler DUNS: 839138955
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-07
• Public Version: 1
• Public Version Date: 2021-07-15
• Public Version Status: New
• Public Device Record Key: 4245c80c-d9d6-4308-830e-43b8709b8060

Device Description

A hermetic seal tester for a Stryker small joint medical power tool

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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47856	Surgical power tool maintenance unit	A device used for the automatic internal lubrication and maintenance of surgical power tools (e.g., pneumatically or electrically driven motors, turbines, or attachments). This device will automatically run programs for the lubrication of the internal components with service oil and flushing with compressed air after external cleansing, but prior to sterilization. This process is intended to improve performance and safety of the surgical instruments. The unit is designed to accept different handpieces which are connected directly or via adaptors to the unit's processing chamber.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848657074940	GS1

Customer Contacts

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