FDA.reportPublic FDA data

Acecide-C

Primary DI
10359900300008
Brand
Acecide-C
Company
BEST SANITIZERS
Model
Acecide-C (PLAC01)
Published
2024-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K091210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091210000ACECIDE-C HIGH LEVEL DISINFECTANT AND STERILANTBest Sanitizers, Inc.2010-02-05MED

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10359900300008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035990030000810359900300008

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection agentA non-patient-contact substance containing a chemical agent(s) intended to destroy microorganisms or inhibit their activity (disinfectant) on medical instrumentation, equipment, and/or facility surfaces (excluding use on contact lenses). It may contain surfactants/cleaning agents or enzymes (e.g., protease, lipase), and may be intended to decalcify equipment. The medical device is intended to be exposed to the substance to achieve disinfection through bathing, wiping, and/or in combination with a disinfection device. It is available in liquid, aerosol, powder, or tablet form; it is not supplied in a dedicated wipe, cap, or other contact-application carrier.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature32 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
627278224
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10359900300039Acecide-CAcecide-C (PLAC04)2024-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05056030400148Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
05056030400155Anaesthetic NeedlesSTERIMEDIX LIMITEDMED2026-03-04
25056030404089Anterior CannulaSTERIMEDIX LIMITEDMED2026-02-24
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