FDA.reportPublic FDA data

JMU

Primary DI
00840456201831
Brand
JMU
Company
JMU DENTAL, INC
Model
32116001
Device description
JMU Autoclave Sterilization Wrap Sheets (CSR), crepe paper, 60grams, 15"x15", blue, 100pcs/bag
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
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
00840456201831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456201831008404562018318404562018310840456201831

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

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
00840456201053JMU321130012026-06-05
00840456201060JMU321130022026-06-05
00840456201077JMU321130032026-06-05
00840456201275JMU321010102026-06-05
00840456201282JMU321010112026-06-05
00840456201299JMU321010122026-06-05
00840456201305JMU321010152026-06-05
00840456201312JMU321010142026-06-05
00840456201848JMU321160022026-06-05
00840456201855JMU321160032026-06-05
00840456201862JMU321160042026-06-05
00840456201879JMU321160052026-06-05
00840456201886JMU321160062026-06-05
00840456201893JMU321160072026-06-05
00840456201909JMU321160082026-06-05
00840456201916JMU321160092026-06-05
00840456201923JMU321160102026-06-05
00840456201930JMU321160112026-06-05
00840456201947JMU321160122026-06-05
00840456202951JMU321010162026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201053JMUJMU DENTAL, INCJOJ2026-06-05
00840456201060JMUJMU DENTAL, INCJOJ2026-06-05
00840456201077JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCJOJ2026-06-05
00840456201275JMUJMU DENTAL, INCFRG2026-06-05
00840456201282JMUJMU DENTAL, INCJOJ2026-06-05
00840456201282JMUJMU DENTAL, INCFRG2026-06-05
00840456201299JMUJMU DENTAL, INCJOJ2026-06-05
00840456201299JMUJMU DENTAL, INCFRG2026-06-05
00840456201305JMUJMU DENTAL, INCJOJ2026-06-05
00840456201305JMUJMU DENTAL, INCFRG2026-06-05
00840456201312JMUJMU DENTAL, INCJOJ2026-06-05
00840456201312JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCFRG2026-06-05
00840456201848JMUJMU DENTAL, INCJOJ2026-06-05
00840456201855JMUJMU DENTAL, INCFRG2026-06-05
00840456201855JMUJMU DENTAL, INCJOJ2026-06-05
00840456201862JMUJMU DENTAL, INCFRG2026-06-05
00840456201862JMUJMU DENTAL, INCJOJ2026-06-05
00840456201879JMUJMU DENTAL, INCFRG2026-06-05
00840456201879JMUJMU DENTAL, INCJOJ2026-06-05
00840456201886JMUJMU DENTAL, INCFRG2026-06-05
00840456201886JMUJMU DENTAL, INCJOJ2026-06-05
00840456201893JMUJMU DENTAL, INCFRG2026-06-05
00840456201893JMUJMU DENTAL, INCJOJ2026-06-05
00840456201909JMUJMU DENTAL, INCFRG2026-06-05
00840456201909JMUJMU DENTAL, INCJOJ2026-06-05
00840456201916JMUJMU DENTAL, INCFRG2026-06-05
00840456201916JMUJMU DENTAL, INCJOJ2026-06-05
00840456201923JMUJMU DENTAL, INCFRG2026-06-05