EXEL Spinal Needle

Basic Information

• Brand Name: EXEL Spinal Needle
• Primary DI: 10020221269601
• Version / Model: 26960
• Catalog Number: 26960
• Company Name: Exel International
• Labeler DUNS: 180572216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 5
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: fa482c7e-50e1-4ebd-8b9b-275b3945b493

Device Description

Spinal Needle, 18G x 3 1/2, QUINCKE BEVEL

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: No
• 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35212	Spinal needle, single-use	A sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10020221269601	GS1
Package	20020221269608	GS1		2	In Commercial Distribution
Unit of Use	00020221269604	GS1
Package	30020221269605	GS1	Shipping carton	4	In Commercial Distribution
Package	40020221269602	GS1	Shipping carton	10	In Commercial Distribution