Rolko

Basic Information

• Brand Name: Rolko
• Primary DI: 04260676050082
• Version / Model: TGN-R100GR-Hr-1-55/60
• Company Name: Rolko Kohlgrüber GmbH
• Labeler DUNS: 328715693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-05
• Public Version: 1
• Public Version Date: 2023-09-13
• Public Version Status: New
• Public Device Record Key: 63b3efe3-4299-4d42-8656-8620e50ef3db

Device Description

handle for bed lifting pole PGFZ - patient can bring himself into upper position or can simply hold himself in postion.

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
ILZ	Accessories, Traction	Physical Medicine	890.5925	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37510	Patient lifting pole	A device designed as a overhead bar with a hanging handgrip above the occupant of the bed that is attached to a medical bed or secured to the wall behind the bed and used by the occupant to provide support when changing position or pulling themselves into a sitting position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260676050099	GS1	cardboard box	75	In Commercial Distribution
Primary	04260676050082	GS1