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
- 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
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