Prosidio

Basic Information

• Brand Name: Prosidio
• Primary DI: 00860006918705
• Version / Model: L.E. All-in-one endoscopy system V1.0
• Catalog Number: LE001
• Company Name: Prosidio LLC
• Labeler DUNS: 035702151
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-06
• Public Version: 1
• Public Version Date: 2021-06-14
• Public Version Status: New
• Public Device Record Key: dc66b78d-eca3-4085-92d0-87adb528c210

Device Description

The Prosidio L.E. all-in-one camera system is an all-in-one camera system for rigid and flexible endoscopes.

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
FWL	Camera, Cine, Endoscopic, Without Audio	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34540	Endoscopic video image processing/light source system	A mains electricity (AC-powered) unit/assembly that, when used with an appropriate endoscope (not included), is designed to both: 1) produce a source of cold light for endoscopic imaging; and 2) receive and process electronic video image signals sent from the endoscope/endoscopic video camera. It may additionally include image recording features and an image display monitor, however it does not include features to steer, propel or otherwise control the movement of the endoscope.	No	Active
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860006918705	GS1