FDA.reportPublic FDA data

JMU

Primary DI
00840456213575
Brand
JMU
Company
JMU DENTAL, INC
Model
20635001
Device description
JMU sterile 6" wooden tongue depressors, 100 pcs/box.
Published
2026-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMADepressor, Tongue, Non-Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMADepressor, Tongue, Non-SurgicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840456213575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840456213575008404562135758404562135750840456213575

GMDN Terms#

Term, Definition table
TermDefinition
Tongue depressor, examination, single-useA hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.

Regulatory Flags#

DUNS number
081258380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
00840217910538Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
00840217910552Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
00840217910576Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
00840217910590Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
20840217910532Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
20840217910556Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
20840217910570Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
20840217910594Ace MedicalEBNER MEDICAL, LLCFMA2026-08-12
00609576700095Puritan®Puritan Medical ProductsFMA2026-07-20
00609576700101Puritan®Puritan Medical ProductsFMA2026-07-20
00609576700118Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700010Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700027Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700034Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700041Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700058Puritan®Puritan Medical ProductsFMA2026-07-20
30609576700188Brightwood®Puritan Medical ProductsFMA2026-07-20
00840456200278JMUJMU DENTAL, INCFMA2026-07-10
00840456213605JMUJMU DENTAL, INCFMA2026-07-10
00840456213582JMUJMU DENTAL, INCFMA2026-07-08
00840456213599JMUJMU DENTAL, INCFMA2026-07-08
05060212050687Bruenings Tongue Depressor, 190mmDTR MEDICAL LIMITEDFMA2026-06-10
M2207250003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769000Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770001Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
05010058083608InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
05010058183605InstrapacROBINSON HEALTHCARE LIMITEDFMA2025-09-11
M220720005Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220769003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11
M220770003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.FMA2025-09-11