FDA.report

Monoject

Primary DI
10884521023116
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
31317483
Catalog number
31317483
Device description
Monoject™ Safety In-Room Sharps Container, Transparent Yellow, 3 Gallon
Published
2023-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MMKContainer, sharps

Product Code Classifications

CodeDeviceSpecialtyClass
MMKContainer, SharpsGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10884521023116PackageGS112In Commercial Distribution
20884521023113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088452102311610884521023116
2088452102311320884521023113

GMDN Terms

TermDefinition
Sharps containerA hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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