Ion Pouch FR

Basic Information

• Brand Name: Ion Pouch FR
• Primary DI: 00850081350002
• Version / Model: ENDO-FR-22G-I
• Company Name: PRAXIS MEDICAL LLC
• Labeler DUNS: 939493362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-06
• Public Version: 1
• Public Version Date: 2025-11-14
• Public Version Status: New
• Public Device Record Key: e60c32e8-7afc-4fca-86f0-c1e72543bfc0

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: No
• 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
KTI	Bronchoscope Accessory	Ear, Nose, Throat	874.4680	2

GMDN Terms

Code	Name	Definition	Implantable	Status
10403	Ultrasound aspiration biopsy procedure kit	A collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850081350009	GS1		5	In Commercial Distribution
Primary	00850081350002	GS1

Premarket Submissions

Submission Number	Supplement Number
K230778	000