TM "Rehabilitimed" GR-3P XXL Comfort

Basic Information

• Brand Name: TM "Rehabilitimed" GR-3P XXL Comfort
• Primary DI: 04823097717769
• Version / Model: GR-3P XXL Comfort
• Catalog Number: GR-3P XXL Comfort
• Company Name: REABILITIMED TOV
• Labeler DUNS: 364875768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-05
• Public Version: 1
• Public Version Date: 2025-05-13
• Public Version Status: New
• Public Device Record Key: 218a526e-1873-42c5-810d-6d36626fe418

Device Description

It is an inguinal hernia bandage, with a front fastener, graphite color. It is made of elastic fabric and multilayer material (special velor fabric tripled (glued in a special way with polyurethane foam) with cotton terry cloth), equipped with pockets for pads and an additional inguinal belt with fasteners. The bandage is fastened using textile fasteners on the belt. The pads are installed in the pocket of the bandage on one or both sides (depending on the location of the hernia).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• 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
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63496	Pelvic fracture binder, single-use	A belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04823097717769	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Hip circumference below the waistline by 10 cm (cm): > 115