XtractSR

Basic Information

• Brand Name: XtractSR
• Primary DI: 05060766500188
• Version / Model: FM-5
• Catalog Number: FM-5
• 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: 2024-09-04
• Public Version: 1
• Public Version Date: 2024-09-12
• Public Version Status: New
• Public Device Record Key: 7c023bc8-2bb9-4d19-9ecd-7c3c26e4cc37

Device Description

Xtract™SR Field Mobility 5 Module Complete- FM-5

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: Yes

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 manual device in the form of a portable lightweight platform or sheet with handles on which a patient can be carried in an emergency from an area inaccessible to a conventional ambulance stretcher. It may be designed as a folding stretcher, rescue backet, spine board, or evacuation sheet, and may include patient straps to secure/stabilize the patient. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060766500188	GS1