Trans-Former

Basic Information

• Brand Name: Trans-Former
• Primary DI: 00860001700121
• Version / Model: [T][#]-[Z]
• Catalog Number: Digital Detector Holder
• Company Name: Reina Imaging
• Labeler DUNS: 102370137
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-29
• Public Version: 2
• Public Version Date: 2023-06-09
• Public Version Status: Update
• Public Device Record Key: bd023470-f914-4896-a406-58e28e8d7663

Device Description

Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility

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: 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
IXY	Holder, Radiographic Cassette, Wall-Mounted	Radiology	892.1880	1

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	00860001700121	GS1

Customer Contacts

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