FDA.reportPublic FDA data

Ace Medical

Primary DI
00840217910538
Brand
Ace Medical
Company
EBNER MEDICAL, LLC
Model
CMVATD-S001
Device description
Adult EO Sterile Tongue Depressor 150mm x 17mm x 1.6mm
Published
2026-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
00840217910538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217910538008402179105388402179105380840217910538

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.

Contacts#

Phone, Email table
PhoneEmail
800-822-0314info@acemedicalco.com

Regulatory Flags#

DUNS number
106135367
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
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
00840217910170Ace Medical CompanyAA4021010AA40210102026-08-13
00840217910187Ace Medical CompanyAA4021015AA40210152026-08-13
00840217910194Ace Medical CompanyAA4021023AA40210232026-08-13
00840217910200Ace Medical CompanyAA4021223AA40212232026-08-13
00840217910217Ace Medical CompanyAA4021215AA40212152026-08-13
00840217910224Ace Medical CompanyAA4021410AA40214102026-08-13
00840217910231Ace Medical CompanyAA4021415AA40214152026-08-13
00840217910248Ace Medical CompanyAA40214232026-08-13
00840217910255Ace Medical CompanyAA4021605AA40216052026-08-13
00840217910262Ace Medical CompanyAA4021608AA40216082026-08-13
00840217910279Ace Medical CompanyECA-A008ECA-A0082026-08-13
00840217910286Wiggins Medical90-070-25FB90-070-25FB2026-08-13
00840217910293Ace Medical CompanyER806.000PAER806.000PA2026-08-13
00840217910309Ace Medical CompanyER806.000VAER806.000VA2026-08-13
00840217910316Ace Medical CompanyER300.010ERER300.010ER2026-08-13
00840217910323Ace Medical CompanyER305.200ER1ER305.200ER12026-08-13
00840217910330Ace Medical CompanyER305.150EER305.150E2026-08-13
00840217910347Ace Medical CompanyER300.020BAER300.020BA2026-08-13
00840217910354Ace Medical CompanyER390.070ER390.0702026-08-13
00840217910361Wiggins Medical90-070-18FB2026-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
00840456213575JMUJMU DENTAL, INCFMA2026-07-08
00840456213582JMUJMU DENTAL, INCFMA2026-07-08
00840456213599JMUJMU DENTAL, INCFMA2026-07-08
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