FDA.reportPublic FDA data

JEDMED

Primary DI
M6334801100
Brand
JEDMED
Company
JEDMED INSTRUMENT COMPANY
Model
48-0110
Catalog number
48-0110
Device description
HEADMIRROR & HEADBAND COMPLETE
Published
2020-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HKFMirror, Headband, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HKFMirror, Headband, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M6334801100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Head reflectorA head-worn device consisting of a circular concave mirror (reflector) attached to a headband designed to reflect light to a site of examination/minor intervention (e.g., the nose, throat, or body surface) on a patient. The examiner wears the device on his/her head, places the reflector in front of one eye, and views the site through a small hole in the centre of the reflector. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
092987189
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6339982060JEDMED99-820699-82062023-02-03
M6339977070JEDMED99-770799-77072023-02-03
M6339977080JEDMED99-770899-77082023-02-03
M6339977090JEDMED99-770999-77092023-02-03
M6339977100JEDMED99-771099-77102023-02-03
M6339977110JEDMED99-771199-77112023-02-03
M6339977120JEDMED99-771299-77122023-02-03
M6339977400JEDMED99-774099-77402023-02-03
M6339977410JEDMED99-774199-77412023-02-03
M6339977420JEDMED99-774299-77422023-02-03
M6339977430JEDMED99-774399-77432023-02-03
M6339977450JEDMED99-774599-77452023-02-03
M6339977460JEDMED99-774699-77462023-02-03
M63399774610JEDMED99-7746-199-7746-12023-02-03
M6339977470JEDMED99-774799-77472023-02-03
M6339977480JEDMED99-774899-77482023-02-03
M6339977490JEDMED99-774999-77492023-02-03
M6339977500JEDMED99-775099-77502023-02-03
M6339978000JEDMED99-780099-78002023-02-03
M6339978100JEDMED99-781099-78102023-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770408986Bausch + LombBausch & Lomb IncorporatedHKF2025-08-04
00840183519841BR Surgical, LLCBR Surgical, LLCHKF2023-03-24
04045396214545clar N 55, LED 6 V, incl. lithium batteriesRudolf Riester GmbHHKF2021-07-19
M6334801200JEDMEDJEDMED INSTRUMENT COMPANYHKF2020-09-01
00840183503697BR Surgical, LLCBR Surgical, LLCHKF2020-08-25
10649111324116SklarSKLAR CORPORATIONHKF2019-03-13
10649111325090SklarSKLAR CORPORATIONHKF2019-03-13
10649111325281SklarSKLAR CORPORATIONHKF2019-03-13