FDA.reportPublic FDA data

Micro-Scientific

Primary DI
10739470500013
Brand
Micro-Scientific
Company
MICRO-SCIENTIFIC, LLC
Model
MICROCIDE1
Device description
Micro-Cide 28 HLD - 3 % Glutaraldehyde Reusable Sterilizing and High Level Disinfecting Solution
Published
2016-09-07
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
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
10739470500013PackageGS14In Commercial Distribution
00739470500016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1073947050001310739470500013
00739470500016007394705000167394705000160739470500016

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080214481
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
false
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
00739470000011Micro-Scientific Enzyclean IIEZ2025-04-29
00739470000028Micro-Scientific EnzycleanEBL2025-04-29
00739470000066Micro-Scientific MicroKleen HSDB2025-04-29
00739470000158Micro-Scientific Enzyclean II LSEM2025-04-29
00739470000172Micro-Scientific MicroKleen LSDMM2025-04-29
00739470400163Micro-Scientific Enzyclean IVEME2025-04-29
10739470000018Micro-Scientific Enzyclean IIEZ2025-04-29
10739470000025Micro-Scientific EnzycleanEBL2025-04-29
10739470000063Micro-Scientific MicroKleen HSDB2025-04-29
10739470000155Micro-Scientific Enzyclean II LSEM2025-04-29
10739470000179Micro-Scientific MicroKleen LSDMM2025-04-29
50739470400168Micro-Scientific Enzyclean IVEME2025-04-29
00739470000356Micro-Scientific Opticide Max Disinfectant CleanerNEOMG2022-08-24
00739470000363Micro-Scientific Opticide Max Disinfectant CleanerNEOMG2022-08-25
00739470100025Micro-Scientific Opti-Cide3NE20GC2022-08-25
00739470100049Micro-Scientific Opti-Cide3NE20GC2022-08-25
00739470100063Micro-Scientific Opti-Cide3NE20GC2022-08-25
00739470100070Micro-Scientific Opti-Cide3 RINE2092022-08-25
00739470100094Micro-Scientific Opti-Cide3 Instrument Soak with Rust InhibitorNE2092022-08-25
00739470100100Micro-Scientific Opti-Cide3NE20GC2022-08-25

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