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
00840456225424JMU368150012026-10-14
00840456225431JMU368150022026-10-14
00840456225332JMU369430022026-10-13
00840456225349JMU369430032026-10-13
00840456225394JMU463070032026-10-13
00840456225400JMU361020042026-10-13
00840456225417JMU361020052026-10-13
00840456225271JMU520210022026-10-12
00840456224656JMU229080452026-10-09
00840456224663JMU229080462026-10-09
00840456224670JMU229080472026-10-09
00840456224687JMU229080482026-10-09
00840456224694JMU229080492026-10-09
00840456224700JMU229080502026-10-09
00840456224717JMU229080512026-10-09
00840456224724JMU229080522026-10-09
00840456224731JMU229080532026-10-09
00840456225264JMU520210012026-10-09
00840456224861JMU410122532026-09-30
00840456224878JMU410122542026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06954454000120COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
06954454000298COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
06954454000304COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
06954454000328COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
06954454000335COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
06954454000342COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
06954454000359COTISENHuanghua Promisee Dental Co., Ltd.EIF2026-10-20
D955RETWIED01Paul BandittTerlain Enterprises, Inc.EIF2026-09-25
00810194403415AiraAIRA, LLCEIF2026-08-26
08800325900809Perfit OneMLVatech mcis Co., LtdEIF2026-07-22
08800325901202Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901219Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901226Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901233Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901240Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901257Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901264Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901271Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901288Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901295Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901301Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901318Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901325Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901332Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901349Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901356Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901363Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901370Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901387Perfit OneMLVatech mcis Co., LtdEIF2026-07-20
08800325901394Perfit OneMLVatech mcis Co., LtdEIF2026-07-20