Trenstop

Basic Information

• Brand Name: Trenstop
• Primary DI: 00810105030273
• Version / Model: 1-1002-001
• Company Name: COMPOSITE MANUFACTURING, INC.
• Labeler DUNS: 947090650
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-13
• Public Version: 3
• Public Version Date: 2021-07-08
• Public Version Status: Update
• Public Device Record Key: 51e88f67-680c-4477-ab0d-ca929ef620e1

Device Description

Carbon Fiber Trendelenburg restraint table accessory. Designed for preventing patient movement while using the Trendelenburg position for surgical procedures. Device is attached to the operating table's side rails via accessory clamps.

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: 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
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62650	Operating table torso positioner	A preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) 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	00810105030273	GS1

Customer Contacts

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