Cytosponge

Basic Information

• Brand Name: Cytosponge
• Primary DI: 20884521767789
• Version / Model: CYTO-201
• Company Name: Covidien LP
• Labeler DUNS: 058614483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2021-11-11
• Public Version: 2
• Public Version Date: 2022-05-30
• Public Version Status: Update
• Public Device Record Key: 8e73b815-a756-4f54-8db0-cab587b30ff5

Device Description

Cell Collection 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EOX	Esophagoscope (flexible or rigid)	Ear, Nose, Throat	874.4710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42537	Cytology scraper, single-use	A wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20884521767789	GS1
Unit of Use	10884521767782	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K181020	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry