N/A

Basic Information

• Brand Name: N/A
• Primary DI: 10705036022947
• Version / Model: ECS33B
• Catalog Number: ECS33B
• Company Name: ETHICON ENDO-SURGERY, LLC
• Labeler DUNS: 044606982
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-20
• Public Version: 1
• Public Version Date: 2022-01-28
• Public Version Status: New
• Public Device Record Key: debe8164-1478-4d70-9f78-1443f39ac56e

Device Description

CIRCULAR MECH XL SEAL 33MM

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
59875	Intraluminal circular stapler, single-use	A sterile, hand-held, manual surgical instrument intended to be used during open or laparoscopic surgical procedures of the alimentary tract, to create anastomoses (e.g., end-to-end, end-to-side, or side-to-side) via intraluminal (within the lumen) resection. It is designed to connect two portions of lumen (e.g., colon) with a single or multiple circular rows of staples, and then cut out the tissue within the staple line to create a new channel. This device operates via a manual lever mechanism and may be available in a variety of sizes appropriate to a specific luminal diameter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20705036022944	GS1	BOX	3	In Commercial Distribution
Primary	10705036022947	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K201280	000