EEA

Basic Information

• Brand Name: EEA
• Primary DI: 20884521047416
• Version / Model: EEATAID21D
• Catalog Number: EEATAID21D
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-18
• Public Version: 2
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: ff0b38ee-db85-4dc5-822f-40f7c08127a2
• Distribution End Date: 2020-08-13

Device Description

Introducer 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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FZX	Guide, surgical, instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11262	Rectal dilator, reusable	A surgical instrument designed to dilate the anal sphincter and canal when the size of the anal opening may interfere with its function or the passage of an examining instrument. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521047419	GS1	CASE	6	Not in Commercial Distribution	2020-08-13
Primary	20884521047416	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	21	Millimeter

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: – 130 Degrees Fahrenheit