ISI

Basic Information

• Brand Name: ISI
• Primary DI: 00810045920504
• Version / Model: Foam Pad - Ultra Light / Self Supporting / Free Standing
• Catalog Number: PD-125
• Company Name: INSTRUMENT SPECIALISTS, INC.
• Labeler DUNS: 041517095
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-23
• Public Version: 1
• Public Version Date: 2020-07-31
• Public Version Status: New
• Public Device Record Key: 33cd7fa6-3728-4631-a783-764b6fda98a4

Device Description

3" Contoured Foam Pad - Ultra Light / Self Supporting / Free Standing

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FSE	Table, Operating-Room, Manual	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36608	Orthopaedic operating table top	A component of a modular operating table designed as a detachable table top to support a patient during orthopaedic surgical procedures. Its surface consists of articulated sections that can be adjusted; it might be intended to provide traction, and may have x-ray transparent features. It is often intended to be used with additional patient positioners.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810045920504	GS1