WIN10 CPU UPGRADE FOR GSL(IN WARRANTY)

Basic Information

• Brand Name: WIN10 CPU UPGRADE FOR GSL(IN WARRANTY)
• Primary DI: 00849832013488
• Version / Model: 23GSLWARW10CPU
• Company Name: Leica Biosystems Richmond, Inc.
• Labeler DUNS: 082930884
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-09
• Public Version: 2
• Public Version Date: 2020-08-20
• Public Version Status: Update
• Public Device Record Key: 9c615488-18e5-449c-bef4-a76c18357870

Device Description

WIN 10 CUP UPGRADE FOR GSL (IN WARRANTY)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• 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
JOY	DEVICE, AUTOMATED CELL-LOCATING	Hematology	864.5260	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38452	Desktop computer	A non-dedicated, electrically-powered computer designed to be stationary on a desk or other work platform. It typically includes a microprocessor [central processing unit (CPU)], a monitor, and a keyboard/mouse. When used with dedicated software the computer may function as a medical device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00849832013488	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K042542	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify

Storage Conditions

• Type: Special Storage Condition, Specify