FDA.reportPublic FDA data

JMU

Primary DI
00840456201282
Brand
JMU
Company
JMU DENTAL, INC
Model
32101011
Device description
JMU Self-Sealing Sterilization Pouches (with internal and external indicators), 2-3/4"x10", 200pcs/box
Published
2026-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162258000Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd.2017-04-28FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456201282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456201282008404562012828404562012820840456201282

Regulatory Flags#

DUNS number
081258380
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155123Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155123Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.JOJ2026-10-30
00850091155161Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155178Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155185Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155192Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
06954454006672COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006689COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006696COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006702COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006719COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006726COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006733COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006740COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454013984COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
08404535038446Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-30
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23