Aspen® Rigid Light Handle Cover

Basic Information

• Brand Name: Aspen® Rigid Light Handle Cover
• Primary DI: 00887761000025
• Version / Model: RIG01NS
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 2400
• 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: 85a6a16b-05f4-4767-800d-80ac1d1a3fd6
• Distribution End Date: 2023-09-22

Device Description

Single use, sterile. Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• 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
Primary	00887761000025	GS1
Unit of Use	00887761005433	GS1

Customer Contacts

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