Applicator Clamp Holder

Basic Information

• Brand Name: Applicator Clamp Holder
• Primary DI: 10841962119419
• Version / Model: RT-5100-53
• Catalog Number: RT-5100-53
• Company Name: Qfix
• Labeler DUNS: 808875397
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-05
• Public Version: 2
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: 51c2b65b-726b-45bc-ac12-daa1b60960c2

Device Description

Applicator Clamp Bracket, Post Mounted

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
JAK	System, x-ray, tomography, computed	Radiology	892.1750	2
IYE	Accelerator, linear, medical	Radiology	892.5050	2
KPS	System, tomography, computed, emission	Radiology	892.1200	2
JAI	Couch, radiation therapy, powered	Radiology	892.5770	2
LNH	System, nuclear magnetic resonance imaging	Radiology	892.1000	2
FRZ	DEVICE, PATIENT TRANSFER, POWERED	General Hospital	880.6775	2
OUO	Tomographic imager combining emission computed tomography with nuclear magnetic resonance	Radiology	892.1200	2
LHN	System, radiation therapy, charged-particle, medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40536	Patient lifting system stretcher	A lifting device used together with a patient lifting system to provide a support for an incapacitated patient or a person with a disability that is being lifted in a lying (horizontal) position for transfer and (re)positioning. It is designed as an elongated framework with a solid or soft surface upon which the person to be lifted is placed and contained during the lifting process.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10841962119419	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K160627	000