N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00681490038270
• Version / Model: 1352238
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-10
• Public Version: 4
• Public Version Date: 2021-01-22
• Public Version Status: Update
• Public Device Record Key: 0b863eda-3fe2-4b18-b73f-d6ebd4151e1c

Device Description

DEVICE 1352238 E/Z LOAD PIN

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: Yes
• Has Manufacturing Date: No
• 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
JYM	INSERTER, MYRINGOTOMY TUBE	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33404	Tympanostomy tube inserter, reusable	A hand-held device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as a myringotomy tube, grommet or an aural vent tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00681490038270	GS1

Customer Contacts

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