FDA.report

Monoject

Primary DI
50192253038208
Company
Cardinal Health 200, LLC
Model
8881200060
Catalog number
8881200060
Device description
Standard Hypodermic Needle Aluminum Hub 16 G x 3/4" (1.7 x 19 mm) I
Published
2026-02-10
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

Regulatory Flags

DUNS number
961027315
Device count
100
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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
50192253038208PackageGS110In Commercial Distribution
20192253038207PrimaryGS10
10192253038200Unit of UseGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
50192253038208PackageGS110CASE20192253038207In Commercial Distribution
20192253038207PrimaryGS10
10192253038200Unit of UseGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FMINeedle, Hypodermic, Single Lumen2General Hospital880.5570NIneligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes

TypeValueText
Length0.75 Inch
Needle Gauge16 Gauge

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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