SchureMed

Basic Information

• Brand Name: SchureMed
• Primary DI: 00810014602776
• Version / Model: 800-0119
• Company Name: SCHUERCH CORPORATION
• Labeler DUNS: 964322929
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-03-17
• Public Version: 4
• Public Version Date: 2021-09-01
• Public Version Status: Update
• Public Device Record Key: 9e3d050d-d3f5-4580-a5e5-382669f16b61

Device Description

Bariatric Restraint Strap with Pad

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: No
• 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: 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
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63966	Medical table restraint anchor	A device intended to be fixed to an operating/radiological table to provide a firmly secure point of attachment for a non-rigid restraint (e.g., strap, band, fabric sheet) to help achieve patient positioning and stabilization during a medical procedure. It may be in the form of a piece of flat material with double-sided adhesive, or a rigid sliding pad/plate that is attached to or fits into a matching slot on the medical table or table rails. Disposable positioners/restraints may be included with the device. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810014602776	GS1

Customer Contacts

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