FDA.reportPublic FDA data

JMU

Primary DI
00840456215074
Brand
JMU
Company
JMU DENTAL, INC
Model
21509001
Device description
Dental Plastic File Holder with Measuring, Autoclavable up to 135°C / 275°F, 88.5x20.1x31.2mm, Blue, 1pcs/box, 200boxes/ctn
Published
2025-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456215074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456215074008404562150748404562150740840456215074

GMDN Terms#

Term, Definition table
TermDefinition
Medical device integration rackA device that is designed as an instrument rack (maybe cabinet-like with closed sides) and is used for mounting and organizing several medical devices that are intended to interact (integrated instrumentation). It is typically mobile (on wheels) and has built-in grounded outlets, pull-out shelves, working surfaces, and may even be equipped with a built-in transformer. This device, when supplied with the instrumentation fitted, will become a system and will require product identification of the whole as a system.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081258380
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456224496JMU215080012026-07-29
00840456224502JMU215080022026-07-29
00840456224519JMU215080032026-07-29
00840456224526JMU215080042026-07-29
00840456224533JMU215080052026-07-29
00840456224540JMU215080062026-07-29
00840456224557JMU215080072026-07-29
00840456224564JMU215080082026-07-29
00840456200957JMU319010042026-07-27
00840456202104JMU323010092026-07-27
00840456202418JMU219040102026-07-27
00840456202555JMU465010062026-07-27
00840456202562JMU465010072026-07-27
00840456202579JMU465010082026-07-27
00840456202586JMU465010092026-07-27
00840456202593JMU465010102026-07-27
00840456202692JMU296010022026-07-27
00840456202708JMU296010032026-07-27
00840456206720JMU353540352026-07-27
00840456206737JMU353540362026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800325901240Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901370Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901394Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
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08800325901486Perfit OneMLVatech mcis Co., LtdEIF2026-07-20