FDA.reportPublic FDA data

Nexadental

Primary DI
10868258000237
Brand
Nexadental
Company
Nexa Dental
Model
Mega 3
Device description
bottle
Published
2016-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MEDSterilant, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEDSterilant, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40868258000238PackageGS14In Commercial Distribution
10868258000237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4086825800023840868258000238
1086825800023710868258000237

GMDN Terms#

Term, Definition table
TermDefinition
Glutaraldehyde device sterilantA liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device.

Regulatory Flags#

DUNS number
787972330
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00858293006946PeracidinREPROCESSING PRODUCTS CORPORATIONMED2026-07-24
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25056030403815Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403822Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403839Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403846Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403853Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403860Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403877Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403884Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403891Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403907Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403914Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403921Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403938Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403945Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403952Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030404089Anterior CannulaSTERIMEDIX LIMITEDMED2026-02-24
10705037048755AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
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10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14