FDA.reportPublic FDA data

MEGA3

Primary DI
10817713023014
Brand
MEGA3
Company
ORTHOQUEST, INC.
Model
MEGA3
Device description
MEGA3 3% GLUTARALDEHYDE GALLON BOTTLE
Published
2017-09-19
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
40817713023015PackageGS14In Commercial Distribution
10817713023014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4081771302301540817713023015
1081771302301410817713023014

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
192699952
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817713020105ORAPROETCHINKIT2016-09-20
10817713022901Easy Etch960-062017-03-07
10817713022918EASY ETCH960-04J04942017-03-07
10817713022925EASY ETCH960-012017-03-07
00817713020146ORAPRO960-062016-09-20
10817713022970ORAPROJ815J8152017-05-08
10817713022345ORTHOQUESTL01712018-08-17
10817713022451ORTHOQUESTL02082018-08-17
10817713022246ORTHOQUESTL01092018-08-17
10817713022253ORTHOQUESTL01102018-08-17
10817713022628ORTHOQUESTL02402018-08-17
10817713021836ACCENTA0668H2018-08-17
10817713022444ORTHOQUESTL02072018-08-17
10817713020211Accent A01502016-09-22
10817713020228AccentA01512016-09-22
10817713020235ACCENTA01522016-09-22
10817713020242ACCENTA01532016-09-22
10817713020259ACCENTA01542016-09-22
10817713020327ACCENTA02002016-09-22
10817713020334ACCENTA02012016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858293006939PeracidinREPROCESSING PRODUCTS CORPORATIONMED2026-07-24
00858293006946PeracidinREPROCESSING PRODUCTS CORPORATIONMED2026-07-24
05056030403057Backflush Aspiration HandpiecesSTERIMEDIX LIMITEDMED2026-07-21
05056030403613Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2026-07-21
15056030400688Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403785Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403792Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
25056030403808Formed Irrigating CystotomesSTERIMEDIX LIMITEDMED2026-06-24
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
10885862658166EXACTECHExactech, Inc.MED2025-11-14
10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14