FDA.reportPublic FDA data

Z3

Primary DI
00366975002488
Brand
Z3
Company
BENCO DENTAL SUPPLY CO.
Model
3738-930
Device description
Benco Z3 3.4% 30 DAY GLUT
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10366975002485PackageGS14In Commercial Distribution
00366975002488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1036697500248510366975002485
00366975002488003669750024883669750024880366975002488

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1Gallon

Regulatory Flags#

DUNS number
015108087
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00366975012463GIBSON HEALTHCARE5250-9802018-05-31
00366975012470GIBSON HEALTHCARE5250-9992018-05-31
00366975012487GIBSON HEALTHCARE5251-0142018-05-31
00366975012494GIBSON HEALTHCARE5251-0232018-05-31
00366975012500GIBSON HEALTHCARE5251-0322018-06-04
00366975012517GIBSON HEALTHCARE5251-0412018-06-04
00366975012524GIBSON HEALTHCARE5251-0502018-06-04
00366975012531GIBSON HEALTHCARE5251-0692018-06-04
00366975012548GIBSON HEALTHCARE5251-1032018-06-04
00366975012555GIBSON HEALTHCARE5251-1122018-06-04
00366975012562GIBSON HEALTHCARE5251-1212018-06-04
00366975012678GIBSON HEALTHCARE5251-0782018-06-04
00366975012685GIBSON HEALTHCARE5251-0872018-06-04
00366975012692GIBSON HEALTHCARE5251-0962018-06-04
00366975012708GIBSON HEALTHCARE5251-1302018-06-04
00366975072108Sterling6904-7452026-08-27
00366975072115Sterling6904-7542026-08-27
00366975065506Natural Extensions5955-488N35PNK2026-07-30
00366975065513Natural Extensions5955-497N35PNK2026-07-30
00366975065520Natural Extensions5955-504N35PNK2026-07-30

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