Aspen® ALC Plus Light Handle Cover

Basic Information

• Brand Name: Aspen® ALC Plus Light Handle Cover
• Primary DI: 00887761000124
• Version / Model: LT-ALC01
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-17
• Public Version: 7
• Public Version Date: 2024-01-04
• Public Version Status: Update
• Public Device Record Key: dee95571-2294-41a8-8d00-1a13394dc541
• Distribution End Date: 2023-09-22

Device Description

Intent ot use provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or staff working in the sterile field.

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: Yes
• 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
FTA	Light, surgical, accessories	General, Plastic Surgery	878.4580	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10887761000121	GS1		18	Not in Commercial Distribution	2023-09-22
Primary	00887761000124	GS1

Customer Contacts

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