Sterile Equipment Cover

Basic Information

• Brand Name: Sterile Equipment Cover
• Primary DI: 10845225012707
• Version / Model: PBKBG
• Catalog Number: PBKBG
• Company Name: Philips Image Guided Therapy Corporation
• Labeler DUNS: 018860556
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 8
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: ccb8745f-1361-4c94-b5db-e4294a11f911

Device Description

Sterile Equipment Cover for R100 Pullback Device

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: Yes
• 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: Yes
• 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
KKX	Drape, Surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10845225012707	GS1
Package	20845225012704	GS1	Box	80	In Commercial Distribution
Package	00845225012700	GS1	Box	10	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052395	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from sunlight