FDA.reportPublic FDA data

DEXIS Platinum™ intraoral sensor sheaths

Primary DI
EKAV100826680
Brand
DEXIS Platinum™ intraoral sensor sheaths
Company
DEXIS LLC
Model
1.008.2668
Catalog number
PLU975019
Device description
100 Count
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MMPCover, barrier, protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMPCover, Barrier, ProtectiveGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV100826680PrimaryHIBCC0
0EKAV100826680Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/equipment drape, single-use, non-sterileA non-sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various instruments/equipment (e.g., dental chairs, treatment tables), to provide a barrier against cross-contamination in the home or healthcare facility. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18888833947support@dexis.com

Regulatory Flags#

DUNS number
019717844
Device count
100
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV100879340DEXIS 10 (DEXIS Imaging Suite)101.008.79342022-01-21
EKAV101244750DEXIS™ Software111.012.44752021-11-12
EKAV101289030DEXcam3™ intraoral cameras1.012.89031.012.89032021-11-12
EKAV101289070DEXcam3™ intraoral cameras1.012.89071.012.89072021-11-12
EKAV082250710DEXIS Platinum™ intraoral sensor0.822.5071PLU5101S2016-09-24
EKAV082250730DEXIS Platinum™ intraoral sensor0.822.5073PLU5102C2016-09-24
EKAV082251940DEXIS Platinum™ intraoral sensor0.822.5194PLU6902016-09-24
EKAV100713330DEXcam3™ intraoral cameras1.007.1333PLU7902016-09-24
EKAV100719690DEXcam3™ intraoral cameras1.007.1969PLU7912016-09-24
EKAV100730420DEXIS Platinum™ intraoral sensor1.007.3042PLU5101I2016-09-24
EKAV100898740DEXIS Platinum™ intraoral sensor1.008.9874PLU690K2016-09-24
EKAV100898770DEXIS Platinum™ intraoral sensor1.008.9877PLU690R2016-09-24
EKAV101034080DEXIS™ Software9PLU2362017-04-14
EKAV101034090DEXIS™ Software9PLU2352017-04-14
EKAV101034110DEXIS™ Software9PLU3492017-04-14
EKAV101034120DEXIS™ Software9PLU2382017-04-14
EKAV101135330DEXIS™ Software11101244792016-12-19
EKAV101149840DEXcam4™ Intra-oral camera1.011.4984PLU7602016-09-24
EKAV101149960DEXcam4™ Intra-oral camera1.011.4996PLU7610K2016-09-24
EKAV101184170DEXIS Platinum™ intraoral sensor1.011.8417PLU5109S2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10195327422202Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2023-06-04
10080196900701Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
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10193489490497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771442Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771466Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771473Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771480Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10193489771497Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327052584Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
10195327057404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2022-08-04
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M752SS1707870STRADISSTRADIS MEDICAL, LLCMMP2022-05-31
M75240290SCC0Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-05-27
M7521001NS0Stradis Medical, LLC.STRADIS MEDICAL, LLCMMP2022-04-26
10195327004224Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMP2021-10-03
10080196497591MedlineMEDLINE INDUSTRIES, INC.MMP2021-07-16
10884389028414MedlineMEDLINE INDUSTRIES, INC.MMP2021-02-11
10888277677975MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.MMP2021-01-29
10884389029510ACCUFITMEDLINE INDUSTRIES, INC.MMP2021-01-26
10080196073160MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-31
10080196001804MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23
10884389001806MedlineMEDLINE INDUSTRIES, INC.MMP2020-12-23
10080196073191MedlineMEDLINE INDUSTRIES, INC.MMP2020-11-26