Manan Medical Products, Inc.

Basic Information

• Brand Name: Manan Medical Products, Inc.
• Primary DI: 00859013006161
• Version / Model: GWI1802EUS
• Catalog Number: GWI1802EUS
• Company Name: MANAN MEDICAL PRODUCTS, INC.
• Labeler DUNS: 831737957
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-26
• Public Version: 4
• Public Version Date: 2021-07-19
• Public Version Status: Update
• Public Device Record Key: 83126196-8a2b-4919-b159-0194fcbd137f
• Distribution End Date: 2019-03-02

Device Description

18GA.ETW X 2.75" Guide Wire Introducer Needle

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61502	Vascular catheter introduction needle	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to make the initial percutaneous puncture to access a vein and/or artery during vascular catheterization. It is available in a variety of forms to enable a catheter to be introduced directly, or a guidewire to be introduced (Seldinger technique); the therapeutic or diagnostic aspiration of fluids may be achieved during its placement. Its lumen is not intended to be filled with an obturator/dilator and it does not include additional access devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20859013006165	GS1	Unit Boxes	10	Not in Commercial Distribution	2019-03-02
Package	10859013006168	GS1	Tyvek Pouch	10	Not in Commercial Distribution	2019-03-02
Primary	00859013006161	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K851834	000

Device Sizes

Type	Value	Unit	Text
Length	2.75	Inch