Coulmed

Basic Information

• Brand Name: Coulmed
• Primary DI: 10810087352360
• Version / Model: TSK21
• Catalog Number: TSK21
• Company Name: Coulmed Products Group LLC
• Labeler DUNS: 047115479
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-06
• Public Version: 1
• Public Version Date: 2023-01-16
• Public Version Status: New
• Public Device Record Key: 429d3b77-1794-4afe-a56a-1359d8657cc7

Device Description

Replacement Pad for Stryker 1060 OB/GYN Stretcher: 2 piece set; Body Section: 26"W x 50"L x 4"T and Leg/Foot Section: 27"W x 30"L x 3"T. Both sections include Standard Foam with 4-Way Stretch Conductive Covering.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
LWG	SURGICAL TABLE CUSHION	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36063	Stretcher mattress	A large, flat, cushion or pad with a strong cover filled with a resilient material (e.g., foam rubber) designed to be used on a stretcher to provide patient comfort whilst they lie upon it. It is much thinner than a bed mattress and is placed on top of, and typically secured to, the stretcher support platform covering this area. This is a general-purpose device that has no special therapeutic purpose.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10810087352360	GS1