RESORB X

Basic Information

• Brand Name: RESORB X
• Primary DI: 00888118096982
• Version / Model: 52-400-98-04
• Company Name: KLS-Martin L.P.
• Labeler DUNS: 826499238
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-06-19
• Public Version: 2
• Public Version Date: 2020-06-30
• Public Version Status: Update
• Public Device Record Key: a43a9561-5835-4450-a640-32231b972f92

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Manufacturing Date: No
• 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
IRQ	UNIT, HEATING, POWERED	Physical Medicine	890.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47744	Surgical water bath system	An assembly of devices designed for use within the sterile surgical field in an operating room (OR) to heat implants (typically fixation plates and screws) to make them more malleable. The assembly typically consists of a mains electricity (AC-powered) water bath with temperature-regulating controls, a thermometer/thermostats, a timer, a sterilizable water holder (a pan or a tray), and a sterility cover that is placed over the bath to maintain the integrity of the sterile surgical field. The implants are submerged in sterile water or saline solution and typically heated to approximately 60-70? Celsius.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00888118096982	GS1

Customer Contacts

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