Thermasplint

Basic Information

• Brand Name: Thermasplint
• Primary DI: 00645724003649
• Version / Model: SP-1501B-CORD4
• Catalog Number: SP1501BCORD4
• Company Name: Whitehall Manufacturing Co
• Labeler DUNS: 008312423
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-02-11
• Public Version: 1
• Public Version Date: 2019-03-11
• Public Version Status: New
• Public Device Record Key: 2b742da4-860a-4bf7-9b85-38d10bc7a5e9

Device Description

FORMA SPLINT WITH 220V ISRAEL CORD(LG)

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
IRQ	Unit, Heating, Powered	Physical Medicine	890.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17526	Thermoplastic-moulding water bath	A mains electricity (AC-powered) water bath specifically designed for the warming/heating of mouldable plastic materials (thermoplastics) used to create body positioning and body fixation devices, splints, and orthotic devices. It will typically consist of a large water holder (pan) that is temperature-regulated from, e.g., room temperature to 100? Celsius, temperature controls, thermometer/thermostats, timer. Sheets or pre-cut pieces of thermoplastic materials are placed into the water with the temperature set according to the material specifications so that these become soft enough to mould to the required shape.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00645724003649	GS1

Customer Contacts

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