Jelco - 412315
Device Description
A sterile device consisting of a graduated barrel (cylinder) with plunger and an attached retractable-needle, intended to be used to deliver an accurate metered dose of a substance (e.g., medicine or drug) during a patient injection. The syringe is typically made of plastic/silicone with an anti-sticking plunger allowing for smooth plunger movement; after use, the plunger is fully retracted into the barrel providing protection against needle sticks, and rendering the device unusable. It may be referred to as a safety syringe and can be used by healthcare personnel or patients. This is a single-use device.
Environmental Conditions
- 75.00
- 27.00
- 35.00
- 15.00
- 90.00
- 25.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: FMI
Device Name: Needle, Hypodermic, Single Lumen
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: 880.5570
Third Party Flag: Y
Medical Specialty: HO
Code: MEG
Device Name: Syringe, Antistick
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
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 IdentifiersDevice Id: 55019517246252
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019517246258
Package Quantity: 400
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case
Device Id: 35019517246258
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019517246254
Package Quantity: 50
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 15019517246254
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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