STARlite Surgical Illuminator 5-pack

Basic Information

• Brand Name: STARlite Surgical Illuminator 5-pack
• Primary DI: 00812432020347
• Version / Model: 010166
• Catalog Number: 73-6195
• Company Name: LUMITEX, INC.
• Labeler DUNS: 108631797
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-05
• Public Version: 3
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: e02880c1-79e3-43e0-84f0-6be3954eeb67
• Distribution End Date: 2023-07-28

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: 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
65349	Open surgical site internal light	An electrically-powered, light-emitting device that includes a light source and is intended to be placed within, or nearly within, a surgical wound/site for illumination during open surgery. It may be fixed to a surgical instrument (e.g., a retractor) and typically operates with either fibreoptic or LED technology to create cold light. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812432020347	GS1
Package	10812432020344	GS1	Box	5	Not in Commercial Distribution	2023-07-28