X-PAC

Basic Information

• Brand Name: X-PAC
• Primary DI: 00810166521482
• Version / Model: EI3914
• Company Name: EXPANDING INNOVATIONS, INC.
• Labeler DUNS: 081309444
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-02
• Public Version: 2
• Public Version Date: 2025-09-24
• Public Version Status: Update
• Public Device Record Key: 7eaa44f2-026f-426e-a51c-74c6c86ec407

Device Description

Pituitary Rongeur, Straight, 4mm

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
HTX	Rongeur	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32853	Orthopaedic joint/limb rongeur	A hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810166521482	GS1

Customer Contacts

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