NA

Basic Information

• Brand Name: NA
• Primary DI: 00724995216528
• Version / Model: 00711836
• Catalog Number: 00711836
• Company Name: US Endoscopy
• Labeler DUNS: 627879687
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-01-28
• Public Version: 1
• Public Version Date: 2022-02-07
• Public Version Status: New
• Public Device Record Key: 906b84cd-0c41-46b1-9630-e891f8dac64c

Device Description

The Endoscopic Marker is a 5mL single-use solution designed to endoscopically mark lesions in the gastrointestinal tract.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NBG	Marker, colon	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17828	Tissue marking ink	A sterile liquid substance intended to be injected into tissue to identify lesions; it is also used externally on the skin to mark incision sites. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10724995216525	GS1	Box	10	In Commercial Distribution
Primary	00724995216528	GS1
Package	50724995216523	GS1	Case	12	In Commercial Distribution

Customer Contacts

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