TrenGuard™

Basic Information

• Brand Name: TrenGuard™
• Primary DI: 00811836030006
• Version / Model: 56100
• Catalog Number: 56100
• Company Name: Dan Allen Surgical LLC
• Labeler DUNS: 040876183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-17
• Public Version: 3
• Public Version Date: 2022-10-24
• Public Version Status: Update
• Public Device Record Key: 70d0d2ec-c228-4d41-89c2-1bb77dd1fede

Device Description

TrenGuard Patient Support Frame - For use with TrenGuard Packs and accessories.

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
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61129	Patient positioner base plate	A device in the form of a flat plate/bar intended to be attached to an operating/radiological table to function as a supportive foundation to which patient positioning devices can be attached (e.g., arch frame, thermoplastic mask, headrest, head positioner). It is used to facilitate positioning and immobilization of a patient’s body part during intraoperative procedures (e.g., orthopaedic surgery), or radiological procedures that require reproducible positioning [e.g., serial imaging studies, radiation treatment planning, radiation therapy procedures or stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811836030006	GS1