FDA.reportPublic FDA data

IMCO-Micro-Scientific

Primary DI
10815842023639
Brand
IMCO-Micro-Scientific
Company
INDEPENDENT MEDICAL CO-OP, INC.
Model
G28-IMC
Published
2016-07-25
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
10815842023639PackageGS14In Commercial Distribution
00815842023632PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081584202363910815842023639
00815842023632008158420236328158420236320815842023632

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
073436164
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
00815842023403IMCO396-IMC2016-06-16
00815842021546IMCO8683-IMC2016-06-13
00815842021553IMCO8697-IMC2016-06-13
00815842021560IMCO8698-IMC2016-06-13
00815842021577IMCO8699-IMC2016-06-13
00815842023151IMCO1530-IMC2016-06-20
00815842023168IMCO1531-IMC2016-06-20
00815842021478IMCO1698-IMC2016-06-13
00815842021485IMCO661-IMC2016-06-13
00815842021492IMCO662-IMC2016-06-13
00815842021508IMCO663-IMC2016-06-13
00815842021515IMCO697-IMC2016-06-13
00815842021522IMCO698-IMC2016-06-13
00815842021539IMCO699-IMC2016-06-13
00815842021461IMCO1667-IMC2016-06-13
20815842023155IMCO1530-IMC2016-06-20
20815842023162IMCO1531-IMC2016-06-20
00815842023113IMCO1505-IMC2016-06-20
00815842023120IMCO1510-IMC2016-06-20
00815842023137IMCO1520-IMC2016-06-20

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Primary DI, Brand, Company table
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