FDA.reportPublic FDA data

Henry Schein

Primary DI
10304040005368
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
1126976
Catalog number
1126976
Device description
Maxicide OPA 28
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MEDSterilant, medical devices

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120306000RAPICIDE OPA-28Minntech Corp.2012-09-27MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10304040005368PackageGS14In Commercial Distribution
00304040005361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1030404000536810304040005368
00304040005361003040400053613040400053610304040005361

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfectantA substance containing a chemical agent(s) intended to destroy harmful microorganisms or inhibit their activity on a medical device (e.g., surgical or dental instrument); it may also contain surfactants/cleaning agents or biological enzymes (e.g. protease, lipase, amylase), and may in addition be intended to decalcify equipment. The medical device is intended to be exposed to the substance for a specified period of time to achieve disinfection, through bathing, wiping, and/or in combination with a disinfection system/unit; it is not supplied as an aerosol and does not include a wipe.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
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
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14
10304040197018Henry Schein570586857058682026-05-14
10304040059446Henry Schein900445490044542019-02-13
10304040196790Henry Schein570584657058462026-04-21
10304040196806Henry Schein570584957058492026-04-21
10304040196660Henry Schein570583757058372026-04-17
10304040196677Henry Schein570583857058382026-04-17
10304040196684Henry Schein570583957058392026-04-17
10304040196691Henry Schein570584057058402026-04-17
10304040196707Henry Schein570584157058412026-04-17
10304040196714Henry Schein570584257058422026-04-17
10304040196653Henry Schein570583157058312026-04-10
00304040000236Henry Schein100-7773100-77732015-09-25
10304040119034Henry Schein570163357016332020-02-05
10304040119058Henry Schein570163457016342020-02-05
10304040119065Henry Schein570163657016362020-02-05
10304040119089Henry Schein570163857016382020-02-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10705037048755AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041480CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041510CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041596CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041602CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10705037041664CIDEX™ADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
20705037048752AEROZYME™ XTRAADVANCED STERILIZATION PRODUCTS SERVICES INC.MED2025-12-16
10885862658159EXACTECHExactech, Inc.MED2025-11-14
10885862658166EXACTECHExactech, Inc.MED2025-11-14
10885862658173EXACTECHExactech, Inc.MED2025-11-14
10885862658180EXACTECHExactech, Inc.MED2025-11-14
10885862658197EXACTECHExactech, Inc.MED2025-11-14
10885862658203EXACTECHExactech, Inc.MED2025-11-14
10885862658210EXACTECHExactech, Inc.MED2025-11-14
10885862658227EXACTECHExactech, Inc.MED2025-11-14
10885862658234EXACTECHExactech, Inc.MED2025-11-14
65056030402922Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-10-27
35056030400842Anterior Chamber Maintenance CannulaeSTERIMEDIX LIMITEDMED2025-10-10
45056030400139Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2025-10-06
00857635006040Aldahol 1.8ALDEN MEDICAL LLCMED2025-09-12
15056030401807Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
45056030400122Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2025-08-22
25056030401804Bimanual I/A SystemsSTERIMEDIX LIMITEDMED2025-08-22
15056030401012Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
15056030401487Vitreoretinal HandpiecesSTERIMEDIX LIMITEDMED2025-03-25
25056030401316Vitreoretinal CannulaeSTERIMEDIX LIMITEDMED2025-03-25
15056030400961Hydrodissection CannulaeSTERIMEDIX LIMITEDMED2025-02-17