Huestis Medical Flexi-Holder

Basic Information

• Brand Name: Huestis Medical Flexi-Holder
• Primary DI: 00850077007101
• Version / Model: FH410-1
• Company Name: HUESTIS MACHINE CORPORATION
• Labeler DUNS: 001188390
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 29d038b1-e0cb-48e0-867d-9a65222526c7

Device Description

Flexi-Holder W/Artic 36" Arm, Huestis Part # FH410-1

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: No
• Has Serial Number: No
• 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
IXA	Cassette, Radiographic Film	Radiology	892.1850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14473	X-ray film cassette holder	A device designed to position and hold the cassettes containing x-ray film during medical or dental imaging or radiation therapy procedures. It is used in conjunction with multiformat cameras and diagnostic imaging and radiation therapy modalities, e.g., nuclear medicine systems, ultrasound, computed tomography (CT), or magnetic resonance imaging (MRI).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850077007101	GS1

Premarket Submissions

Submission Number	Supplement Number
K792721	000