XtractSR

Basic Information

• Brand Name: XtractSR
• Primary DI: 05060766500096
• Version / Model: XtractSR V4S
• Company Name: T.S.G. ASSOCIATES LLP
• Labeler DUNS: 211458967
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-15
• Public Version: 1
• Public Version Date: 2023-08-23
• Public Version Status: New
• Public Device Record Key: dfb875c8-8805-4336-ac5a-0d96ca684557

Device Description

Portable stretcher

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPP	Stretcher, Hand-Carried	General Hospital	880.6900	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13818	Portable stretcher	A hand-carried device consisting of a lightweight frame, or of two poles with a cloth or metal platform, on which a patient can be carried. It is typically used to transport a patient from areas inaccessible to conventional ambulance stretchers (e.g., mountain or marine sites, difficult indoor situations such as narrow corridors or extremely steep stairways). The patient may be strapped to the device for security.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060766500096	GS1

Customer Contacts

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