FDA.reportPublic FDA data

ProBarrier

Primary DI
H816MBB0528X1
Brand
ProBarrier
Company
MicroCare, LLC
Model
BB-0528X
Catalog number
BB-0528X-1
Device description
Environmental Surface Barrier, 5 x 28 Instrument/equipment drape, x-ray sox
Published
2022-10-26
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
KLCChair, Dental, With Operative Unit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLCChair, Dental, With Operative UnitDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922175000HEALTHPAK CHAIR SOX BARRIERSHealthpak, Inc.1992-08-06KLC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H816MBB0528X2PackageHIBCC10Not in Commercial Distribution
H816BB0528X1PreviousHIBCC0
H816MBB0528X1PrimaryHIBCC0
H816MBB0528X0Unit 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
118518186
Device count
250
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H816MPM10161ProView PlusPM1016PM1016-12022-10-26
H816MPM13181ProView PlusPM1318PM1318-12022-10-26
H816MPM24401ProView PlusPM2440PM2440-12022-10-26
H816MPM27901ProView PlusPM2790PM2790-12022-10-26
H816MPM35541ProView PlusPM3554PM3554-12022-10-26
H816MPM35901ProView PlusPM3590PM3590-12022-10-26
H816MPM54101ProView PlusPM5410PM5410-12022-10-26
H816GEL121Spec Clean Pre Treatment GelGEL12GEL122025-10-23
H816OP1281OptizymeOP128OP1282025-10-23
H816PSC050Spec Clean Ready to Use DisinfectantPSC050PSC0502025-10-23
H816PSC128Spec Clean Ready to Use DisinfectantPSC128PSC1282025-10-23
H816PSC240Spec Clean Ready to Use DisinfectantPSC240PSC2402025-10-23
H816PSC6032Spec Clean Concentrated DisinfectantPSC6032PSC60322025-10-23
H816EZ128Spec Clean Single Enzymatic DetergentEZ128EZ1282025-10-22
H816EZTAB641Spec Clean Enzymatic TabletsEZTAB64EZTAB642025-10-22
H816PCNF128Spec Clean Instrument Detergent AlkalinePCNF128PCNF1282025-10-22
H816PLC128Spec Clean Concentrated Instrument LubricantPLC128PLC1282025-10-22
H816PLR32Spec Clean Instrument LubricantPLR32PLR322025-10-22
H816PREZ128Spec Clean Dual Enzymatic DetergentPREZ128PREZ1282025-10-22
H816PREZ275Spec Clean Dual Enzymatic DetergentPREZ275PREZ2752025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800000996264OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-09-04
07899581340925Dental ChairAlliage S/A Indústrias Médico OdontológicaKLC2025-07-25
08800000995977OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800000995984OSSTEM IMPLANT CO., LTD. CHAIR BUSINESSOsstem Implant Co.,Ltd.KLC2025-04-24
08800053083249Luvis Chair (LC700C)DENTIS CO. ,LTDKLC2024-09-19
H816MBB0312H1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB2930C1ProBarrierMicroCare, LLCKLC2022-10-26
H816MDC0115S1ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0312H2ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB0528X2ProBarrierMicroCare, LLCKLC2022-10-26
H816MBB2930C2ProBarrierMicroCare, LLCKLC2022-10-26
H816MDC0115S2ProBarrierMicroCare, LLCKLC2022-10-26
ERICV00000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVP0000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVS0000110VanguardRitter Concept GmbHKLC2022-08-17
ERICVSP000110VanguardRitter Concept GmbHKLC2022-08-17
06430035420162Planmeca ChairPlanmeca OyKLC2017-05-08
H816BB0312H1BarrierCERTOL INTERNATIONAL, LLCKLC2017-01-13
H816BB0312H2BarrierCERTOL INTERNATIONAL, LLCKLC2017-01-13
H816BB0528X1BARRIERCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB2930C1BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816DC0115S1BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB0528X2BARRIERCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816BB2930C2BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23
H816DC0115S2BarrierCERTOL INTERNATIONAL, LLCKLC2016-09-23