X-PAC

Basic Information

• Brand Name: X-PAC
• Primary DI: 00850001720090
• Version / Model: EI2458
• Catalog Number: EI2458
• Company Name: EXPANDING INNOVATIONS, INC.
• Labeler DUNS: 081309444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-23
• Public Version: 2
• Public Version Date: 2021-03-08
• Public Version Status: Update
• Public Device Record Key: 0b84f399-c4c4-41bb-a615-490b3ad7f17b

Device Description

Bone Packing Bowl

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47741	Orthopaedic cement mixing container, reusable	A device in which an orthopaedic cement dispenser is intended to be placed to maintain the sterility of the dispenser and its contents (orhtopaedic cement) when it is taken out of the sterile field to be mixed by an automatic mixer during a surgical procedure. It is typically made of plastic material and designed to be passed by operating staff from the sterile field to staff who may not be sterile, and back again, without compromising the sterility of its contents. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850001720090	GS1

Customer Contacts

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