FDA.reportPublic FDA data

COVERMAX OPTIMUM HEADREST COVER

Primary DI
D89260705535201
Brand
COVERMAX OPTIMUM HEADREST COVER
Company
MAXILL, INC.
Model
6070553520
Published
2022-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NRUChair, Dental, Without Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRUChair, Dental, Without Operative UnitDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D89260705535201PrimaryHIBCC0
D89260705535200Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Regulatory Flags#

DUNS number
079343581
Device count
500
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D89260705600570AUTOCLAVE TAPE60705600572022-09-19
D89260705600580AUTOCLAVE TAPE60705600582022-09-19
D89260705600590AUTOCLAVE TAPE60705600592022-09-19
00060705811240u-test SI Steam Sterilization Integrator811242016-10-17
D89260705533181POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533182POLYALL CURING LIGHT SLEEVE60705533182022-07-22
D89260705533191POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D89260705533192POLYALL CURING LIGHT SLEEVE60705533192022-07-22
D8926070553525BU1COVERMAX OPTIMUM HEADREST COVER6070553525BU2022-10-20
D8926070553525GN1COVERMAX OPTIMUM HEADREST COVER6070553525GN2022-10-20
D8926070553525LV1COVERMAX OPTIMUM HEADREST COVER6070553525LV2022-10-20
D89260705533601PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533602PHOSPHOR PLATE BARRIER ENVELOPES60705533602022-07-22
D89260705533611PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533612PHOSPHOR PLATE BARRIER ENVELOPES60705533612022-07-22
D89260705533621PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533622PHOSPHOR PLATE BARRIER ENVELOPES60705533622022-07-22
D89260705533651PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22
D89260705533652PHOSPHOR PLATE BARRIER ENVELOPES60705533652022-07-22
D89260705533661PHOSPHOR PLATE BARRIER ENVELOPES60705533662022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971119541323Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2026-03-30
00841709121845MidmarkMIDMARK CORPORATIONNRU2026-03-18
00841336111288Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336108554Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-11-11
00841336110199Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNRU2025-09-28
10194665008383A-decA-DEC, INC.NRU2025-09-18
D178A12H0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
D178A6E0Flight Dental SystemsFlight Dental Systems USA Inc.NRU2025-08-29
06971119541316Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119541880Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
06971119542375Dental chair and accessoriesGuangdong JINME Medical Technology Co., Ltd.NRU2025-07-15
10194665006587A-decA-DEC, INC.NRU2025-05-19
10194665006594A-decA-DEC, INC.NRU2025-05-19
08800266944368Luvis Chair (LC700C-chair only plus)DENTIS CO. ,LTDNRU2025-02-21
10194665007911A-decA-DEC, INC.NRU2025-01-24
D1355370DOME Innovation ChairDome, Inc.NRU2025-01-14
TQ26126151051Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151061Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
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TQ26126151081Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151741Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151881Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151050Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151060Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151070Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151080Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151740Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
TQ26126151880Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.NRU2024-12-09
D06037062730DentalezDentalez Alabama, Inc.NRU2024-11-05
D0603706273PT0DentalezDentalez Alabama, Inc.NRU2024-11-05