EXEL SPINAL NDL 27GX3-1/2"

Basic Information

• Brand Name: EXEL SPINAL NDL 27GX3-1/2"
• Primary DI: 00020221269697
• Version / Model: 26969
• Catalog Number: 26969
• Company Name: Exel International
• Labeler DUNS: 180572216
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-16
• Public Version: 3
• Public Version Date: 2023-12-04
• Public Version Status: Update
• Public Device Record Key: 11544bc8-1f99-4d3b-b082-6b3e269d0aaa

Device Description

EXEL SPINAL NDL 27GX3-1/2", 50/BOX,100/CS, 4CS/CRTN

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: 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
Package	10020221269694	GS1	Inner box	50	In Commercial Distribution
Primary	00020221269697	GS1
Package	20020221269691	GS1	Outer box	2	In Commercial Distribution
Package	30020221269698	GS1	Shipping carton	4	In Commercial Distribution
Package	40020221269695	GS1	Shipping carton	10	In Commercial Distribution

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius