Variable Polarizing Hood

Basic Information

• Brand Name: Variable Polarizing Hood
• Primary DI: 00850033167122
• Version / Model: GMD55100010
• Catalog Number: GMD55100010
• Company Name: GLOBALMEDIA GROUP, LLC
• Labeler DUNS: 103201849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-08
• Public Version: 1
• Public Version Date: 2023-12-18
• Public Version Status: New
• Public Device Record Key: 8c503a7a-5bfd-4f18-8b8e-4727779b4652

Device Description

An instrument that eliminates unwanted glare from surfaces that are being examined.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
PEQ	Accessories To Examination Light	General Hospital	880.6320	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58858	Multi-purpose digital medical camera lens, otoscopic	A non-sterile optical device intended for attachment to a multi-purpose digital medical camera to provide high-resolution focusing of digital imaging data from the external auditory canal and tympanic membrane. It typically facilitates recording of the colour, position, and translucency of the tympanic membrane and is intended to be used with a disposable speculum to limit patient cross-infection. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850033167122	GS1

Premarket Submissions

Submission Number	Supplement Number
K131338	000