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
M63330170506L0JEDMED30-1705 06L30-1705 06L2020-09-01
M63330170506R0JEDMED30-1705 06R30-1705 06R2020-09-01
M63330170579H0JEDMED30-1705 79H30-1705 79H2020-09-01
M6333018340JEDMED30-183430-18342020-09-01
M6333018350JEDMED30-183530-18352020-09-01
M6333018360JEDMED30-183630-18362020-09-01
M6333103500JEDMED31-035031-03502020-09-01
M6333103510JEDMED31-035131-03512020-09-01
M6333104600JEDMED31-046031-04602020-09-01
M6333104750JEDMED31-047531-04752020-09-01
M63331047570JEDMED31-0475 731-0475 72020-09-01
M6333104760JEDMED31-047631-04762020-09-01
M63331047650JEDMED31-0476 531-0476 52020-09-01
M6333104770JEDMED31-047731-04772020-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462922055evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922062evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922079evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922086evonosevonos GmbH & Co. KGHKF2026-08-14
04054462922093evonosevonos GmbH & Co. KGHKF2026-08-14
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