Spot Ex CE Endoscopic Tattoo

Basic Information

• Brand Name: Spot Ex CE Endoscopic Tattoo
• Primary DI: 00893029002199
• Version / Model: GIS-46
• Catalog Number: GIS-46S
• Company Name: GI Supply, Inc.
• Labeler DUNS: 160990313
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-07
• Public Version: 1
• Public Version Date: 2021-07-15
• Public Version Status: New
• Public Device Record Key: 509c8c66-0d11-4198-8bba-4e56ddfad3cd

Device Description

Spot Ex is indicated for endoscopically tattooing lesions in the GI tract for up to 36 months to facilitate clinical surveillance or surgical localization.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• 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
NGB	Test, Glycosylated Hemoglobin, Over The Counter	Hematology	864.7470	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	10893029002196	GS1		10	In Commercial Distribution
Primary	00893029002199	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – Degrees Celsius