Fiber Optic Illuminator

Basic Information

• Brand Name: Fiber Optic Illuminator
• Primary DI: 00869836000314
• Version / Model: 1136-001
• Company Name: I-TEK MEDICAL SOLUTIONS, INC.
• Labeler DUNS: 080599644
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-12-06
• Public Version: 1
• Public Version Date: 2019-01-07
• Public Version Status: New
• Public Device Record Key: 3df3457f-4fb2-4041-9dd0-eb8034ca3aba

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: 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	876.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48036	Surgical instrument fibreoptic light	A sterile device with a fibreoptic bundle core designed to be affixed to the surface of a surgical instrument, typically a retractor, to conduct cold light from a connected fibreoptic light cable and light source into a surgical wound for illumination during a surgical intervention. It typcially emits cold light only through its tip to eliminate glare, and may have a self-adhesive coating for attachment to the surgical instrument. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10869836000311	GS1	Case	25	In Commercial Distribution
Primary	00869836000314	GS1

Customer Contacts

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