FDA.reportPublic FDA data

JMU

Primary DI
D930321010200
Brand
JMU
Company
JMU DENTAL, INC
Model
32101020
Device description
"Self-Sealing Sterilization Pouches (with internal and external indicators), 10-1/2“x17"", 100pcs/box, 1000pcs(10boxes)/case"
Published
2024-12-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
D930321010200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081258380
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840456201756JMU481010012026-05-27
00840456201763JMU481010022026-05-27
00840456201770JMU481010032026-05-27
00840456201787JMU481010042026-05-27
00840456201794JMU481010052026-05-27
00840456221020JMU481010062026-05-27
00840456222423JMU361060082026-05-19
00840456222430JMU361060092026-05-19
00840456222447JMU361060102026-05-19
00840456222454JMU361060112026-05-19
00840456222461JMU361060122026-05-19
00840456222478JMU361060132026-05-19
00840456221532JMU387020762026-05-11
00840456221549JMU387020772026-05-11
00840456221556JMU387020782026-05-11
00840456221563JMU387020792026-05-11
00840456221570JMU387020802026-05-11
00840456221587JMU387020812026-05-11
00840456221594JMU387020822026-05-11
00840456221600JMU387020832026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842942015038PRIMEDpriMED Medical Products IncFRG2026-06-04
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00842942015052PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015069PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015076PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015090PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015106PRIMEDpriMED Medical Products IncFRG2026-06-04
10665973032860DUKALDukal LLCJOJ2026-06-01
10665973032877DUKALDukal LLCJOJ2026-06-01
10665973032884DUKALDukal LLCJOJ2026-06-01
00842942012990PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013003PRIMEDpriMED Medical Products IncFRG2026-05-29
00842942013010PRIMEDpriMED Medical Products IncFRG2026-05-29