Aligned Medical Solutions

Basic Information

• Brand Name: Aligned Medical Solutions
• Primary DI: B098AMS86160
• Version / Model: AMS8616
• Catalog Number: AMS8616
• Company Name: Aligned Medical Solutions
• Labeler DUNS: 106580145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-14
• Public Version: 1
• Public Version Date: 2018-12-17
• Public Version Status: New
• Public Device Record Key: 29999939-e2ce-4cb2-aed1-a2e0737a9f7a

Device Description

Nerve Block Tray -RX

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OJG	Neurological tray	Neurology	882.4525	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44064	Neurosurgical procedure kit, medicated	A collection of various sterile neurosurgical instruments, dressings, pharmaceuticals, and the necessary materials used to perform a neurosurgical procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	B098AMS86161	HIBCC	case	20	In Commercial Distribution
Primary	B098AMS86160	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius