EEA

Basic Information

• Brand Name: EEA
• Primary DI: 10884521047563
• Version / Model: HEM3348
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-02
• Public Version: 4
• Public Version Date: 2023-07-12
• Public Version Status: Update
• Public Device Record Key: 113c2f79-7c9c-44db-9133-6cbd9de707c9

Device Description

Hemorrhoid and Prolapse Stapler with DST Series Technology

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• 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
GDW	STAPLE, IMPLANTABLE	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46737	Haemorrhoidal surgical stapler, single-use	A sterile, surgical instrument designed to apply surgical staples to tissue in the anal canal to treat haemorrhoids, particularly the procedure for prolapse and haemorrhoids (PPH) [repositioning of the anal canal mucosa to reduce blood flow to internal haemorrhoids]. It is typically pistol-like in design with a rounded, cylindrical head loaded with staples at the distal end, and operating levers at the proximal end intended to deliver a single- or multiple-circular band(s) of staples, whilst cutting away hemorrhoidal tissue. It may include disposable supportive devices intended to assist the procedure (e.g., rectal dilator, anoscope). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20884521047560	GS1	CASE	3	In Commercial Distribution
Primary	10884521047563	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K083781	000

Device Sizes

Type	Value	Unit	Text
Outer Diameter	33	Millimeter
Height	4.8	Millimeter

Storage Conditions

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