RTK10007 OR Turnover Kit - Table Cover(1), Lift Sheet(1), Armboard Covers(1pr)

Basic Information

• Brand Name: RTK10007 OR Turnover Kit - Table Cover(1), Lift Sheet(1), Armboard Covers(1pr)
• Primary DI: 00787551011722
• Version / Model: RTK10007
• Catalog Number: RTK10007
• Company Name: XODUS MEDICAL, INC.
• Labeler DUNS: 868042664
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-13
• Public Version: 1
• Public Version Date: 2022-12-21
• Public Version Status: New
• Public Device Record Key: 8415ff40-326a-406a-959a-0096408a5e77

Device Description

RTK10007 OR Turnover Kit - Table Cover(1), Lift Sheet(1), Armboard Covers(1pr)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDD	Kit, surgical instrument, disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65175	Operating room turnover kit	A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20787551011726	GS1	CASE	18	In Commercial Distribution
Primary	00787551011722	GS1

Customer Contacts

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