10ml Suresafe Manual Retractable Syringe 21G x 1 1/2"

Basic Information

• Brand Name: 10ml Suresafe Manual Retractable Syringe 21G x 1 1/2"
• Primary DI: 05391530750875
• Version / Model: 10ml 21G x 1 1/2"
• Catalog Number: FD-MSSIC10-21
• Company Name: DMC MEDICAL LIMITED
• Labeler DUNS: 989772017
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-06
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d09afd90-c762-4684-923f-129a68c1e1e0

Device Description

10ml Suresafe Manual Retractable 21G x 1 1/2" Syringe

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MEG	Syringe, Antistick	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45042	Metered-delivery hypodermic syringe/needle	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05391530750899	GS1		12	In Commercial Distribution
Package	05391530750882	GS1		100	In Commercial Distribution
Primary	05391530750875	GS1

Premarket Submissions

Submission Number	Supplement Number
K141349	000