FDA.report

Monoject

Primary DI
50192253030653
Brand
Monoject
Company
Cardinal Health 200, LLC
Model
8881135609
Catalog number
8881135609-
Device description
35 mL Syringe Barrel Assembly
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
50192253030653PackageGS115In Commercial Distribution
20192253030652PrimaryGS10
10192253030655Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5019225303065350192253030653
2019225303065220192253030652
1019225303065510192253030655

GMDN Terms

TermDefinition
Irrigation syringeA general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). This is a single-use device.

Device Sizes

TypeValueUnit
Total Volume35Milliliter

Sterilization Methods

Method

Regulatory Flags

DUNS number
961027315
Device count
10
DM exempt
false
Premarket exempt
true
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

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