- Physicians Office Resource

Syringe with fixed needle
Syringe with fixed needle - For use only with GONAL-f Multi-Dose 600 IU/mL FSH - BS-N1A2713U10

Device Description

A sterile device consisting of a graduated barrel (cylinder) with plunger intended to be used to deliver (inject) or withdraw an accurate metered dose of a fluid to/from the body. The application of the content of this device may be in conjunction with an injector device (transcutaneous delivery) or through the traditional use of a needle (subcutaneous delivery). It may allow for retraction of an attached needle (safety syringe); the needle is not included. This is a single-use device.

Environmental Conditions

Special Storage Condition, Specify

Do not store at extreme temperature and humidity.

Device Sizes

Syringe Volume: 1 Milliliter

Needle Length: 12 Millimeter

Needle Outer Diameter: 0.4 Millimeter

Needle Length: 0.5 Inch

Needle Gauge: 27 Gauge

Syringe Volume: 1 Milliliter
Needle Length: 12 Millimeter
Needle Outer Diameter: 0.4 Millimeter
Needle Length: 0.5 Inch
Needle Gauge: 27 Gauge

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: FMF

Device Name: Syringe, Piston

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HO

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 880.5860

Third Party Flag: Y

Medical Specialty: HO

Device Identifiers

Device Id: 55413206214209

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 35413206214205

Package Quantity: 120

Package Discontinue Date: 6/19/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Carton

Device Id: 35413206214205

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 05413206214204

Package Quantity: 10

Package Discontinue Date: 6/19/2018 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Plastic Box

Device Id: 05413206214204

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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