Sterling Washers

Basic Information

• Brand Name: Sterling Washers
• Primary DI: 10841736110697
• Version / Model: P1500-FLX2
• Catalog Number: P1500-FLX2
• Company Name: SKYTRON LLC
• Labeler DUNS: 078375583
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-22
• Public Version: 3
• Public Version Date: 2023-10-04
• Public Version Status: Update
• Public Device Record Key: 460bb449-6f48-4034-af9b-1228680581b9

Device Description

Flexible load carrier for processing in 2 levels w/ removable grids and spray arms

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: 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
MEC	Disinfector, medical devices	General Hospital	880.6992	2

GMDN Terms

Code	Name	Definition	Implantable	Status
66797	Surgical instrument washer/disinfector (chemical/thermal)	An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841736110697	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -20 – 70 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 0 – 80 Percent (%) Relative Humidity