Fiber Optic Illuminator

Basic Information

• Brand Name: Fiber Optic Illuminator
• Primary DI: 00869836000321
• Version / Model: 1102-001
• 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: 2019-05-28
• Public Version: 1
• Public Version Date: 2019-06-05
• Public Version Status: New
• Public Device Record Key: 08edcedb-e053-4a4c-9a74-33583566ab7f

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	10869836000328	GS1	Case	1	In Commercial Distribution
Primary	00869836000321	GS1

Customer Contacts

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