LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, TABLE TOP VERSION

Basic Information

• Brand Name: LED LIGHT SOURCE WITH TURRET: ACMI, WOLF, OLYMPUS, KARL STORZ, TABLE TOP VERSION
• Primary DI: 00810040253720
• Version / Model: S 740200LEDTT
• Company Name: GLOBAL SURGICAL CORPORATION
• Labeler DUNS: 824793335
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-21
• Public Version: 2
• Public Version Date: 2024-01-12
• Public Version Status: Update
• Public Device Record Key: 0b8121ce-a0a1-4656-86c2-a6208d1df7ce
• Distribution End Date: 2023-12-31

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ETF	Unit, Examining/Treatment, Ent	Ear, Nose, Throat	874.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44380	ENT cabinet	A stand-alone, furniture-like device designed to store, display, and provide readily accessible for the operator the instruments, devices, and materials, including the local anaesthetics used in ear/nose/throat (ENT) treatments/procedures. This device is used in hospitals and physician's offices and will typically have a worktop intended to facilitate the intervention. The device may include features, e.g., suction and pressure pumps, fibreoptic-light source, built-in electrical outlets. It will have wheels for easy movement.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810040253720	GS1