HSW HENKE-JECT®

Basic Information

• Brand Name: HSW HENKE-JECT®
• Primary DI: 04035873063162
• Version / Model: 5202D000V0
• Catalog Number: 5202D000V0
• Company Name: Henke-Sass, Wolf GmbH
• Labeler DUNS: 317326411
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2020-12-08
• Public Version: 1
• Public Version Date: 2020-12-16
• Public Version Status: New
• Public Device Record Key: a99441be-9827-47e9-ad86-b2f7f0dd52b8

Device Description

HSW HENKE-JECT® 3-TLG. 20 ML BK 21G X 1 1/2 - 0,80 X 40 MM

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
47017	General-purpose syringe, single-use	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035873063179	GS1	CARTON	8	In Commercial Distribution
Primary	04035873063162	GS1
Unit of Use	04035873063155	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	20	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: PROTECT FROM SUNLIGHT, KEEP DRY