NA

Basic Information

• Brand Name: NA
• Primary DI: 04035873044598
• Version / Model: 8300026718
• Catalog Number: 8300026718
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-12
• Public Version: 4
• Public Version Date: 2019-11-22
• Public Version Status: Update
• Public Device Record Key: f7f011cf-2822-487e-b37f-e0469fe7bfe3
• Distribution End Date: 2019-11-21

Device Description

50 ML (60 ML) SYRAMED 3-TLG LUER LOCK

Device Characteristics

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

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35904	Metered-delivery hypodermic syringe	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035873044581	GS1	CARTON	6	Not in Commercial Distribution	2019-11-21
Primary	04035873044598	GS1
Unit of Use	04035873053231	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	50	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Protect from sunlight
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry