FDA.reportPublic FDA data

JMU

Primary DI
D930321160080
Brand
JMU
Company
JMU DENTAL, INC
Model
32116008
Device description
"Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 18""x18"", blue, 100pcs/bag, 1000pcs/case (45*45cm)"
Published
2023-11-01
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181957000Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll GussetedTianchang Jiarui Packaging Material Co., Ltd.2019-07-09FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D930321160080PrimaryHIBCC0

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
00840456200186JMU101070072026-07-06
00840456201435JMU130100122026-07-06
00840456202678JMU233010032026-07-06
00840456203019JMU390010052026-07-06
00840456203026JMU390010062026-07-06
00840456203033JMU390010072026-07-06
00840456203040JMU390010082026-07-06
00840456203057JMU390010092026-07-06
00840456203064JMU390010102026-07-06
00840456203071JMU390010112026-07-06
00840456203088JMU390010122026-07-06
00840456203095JMU390010132026-07-06
00840456206362JMU130100132026-07-06
00840456214305JMU130040052026-07-06
00840456214312JMU130040042026-07-06
00840456214329JMU130080012026-07-06
00840456214336JMU130090022026-07-06
00840456214343JMU130100112026-07-06
00840456214350JMU130100102026-07-06
00840456214367JMU130100092026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201831JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00842942013485PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013645PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013652PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013669PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013676PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942013683PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014888PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014895PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014901PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014918PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014970PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014987PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942014994PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015007PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015014PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015021PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015038PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015045PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015052PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015069PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015076PRIMEDpriMED Medical Products IncFRG2026-06-04
00842942015083PRIMEDpriMED Medical Products IncFRG2026-06-04