Imperial Staddle (Neurosurgery) Tables

Basic Information

• Brand Name: Imperial Staddle (Neurosurgery) Tables
• Primary DI: 07540162041310
• Version / Model: OR-3646F-D
• Catalog Number: OR-3646F-D
• Company Name: Imperial Surgical Ltd
• Labeler DUNS: 245253575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-14
• Public Version: 1
• Public Version Date: 2021-01-22
• Public Version Status: New
• Public Device Record Key: 6a87a0c1-39a0-4a9d-88c9-2191e6317d24

Device Description

34" x 46"Straddle Table w/Std crank hdl & 4-sided Flanged sides

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
FZM	Stool, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13959	Instrument table	A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540162041310	GS1

Customer Contacts

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