FasTract Sternal Retractor

Basic Information

• Brand Name: FasTract Sternal Retractor
• Primary DI: 00899054002302
• Version / Model: RTC-1000
• Company Name: KDL MEDICAL, INC.
• Labeler DUNS: 791048924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-08-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7ce298a7-a7ea-45d2-84f7-47371a0cd95d

Device Description

Sternal Retractor, Reusable

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46771	Sternum spreader	A self-locking surgical instrument designed to force apart the surgically-split sternum (the breastbone) to permit surgical cardiac intervention within the thoracic cavity. This device will typically have two interchangeable profiled, pivoted blades (self-adjusting their angle as the instrument is opened) at the distal end that hook over the margins of the severed sternum, and a ratchet mechanism along its horizontal bar to adjust the blades, parting the sternum and maintain its set position once it has been set. It is also known as a sternum retractor and is available in various designs and sizes. It is made of high-grade stainless steel. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00899054002302	GS1

Customer Contacts

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