Premio 40 - Light 112953

GUDID 03760262493381

The PREMIO 40 Light is an active device intended to illuminate an area or a point of the patient's body in the visible spectrum by a light emission which can be filtered and / or frequency.

SEDATELEC

Fixed examination/treatment room light

• Primary Device ID: 03760262493381
• NIH Device Record Key: 7ccd57e2-ef74-4bb7-8557-eda7b6c19d2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premio 40 - Light
• Version Model Number: PREMIO 40
• Catalog Number: 112953
• Company DUNS: 266031462
• Company Name: SEDATELEC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760262493381 [Primary]

FDA Product Code

• KYT: Light, Examination, Medical, Battery Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-04
• Device Publish Date: 2021-07-27

Devices Manufactured by SEDATELEC

• 03760262490625 - BAT02 Glass rods: 2024-05-03 The BAT02 is designed to massage reflex points or zones in the auricle.
• 03760262490670 - EASYO 1 - Multi Pressure Feeler: 2024-05-03 The pressure feelers are basic tools for auriculotherapy.
• 03760262492902 - PAL130 Pressure feeler 130g: 2024-05-03 The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin a
• 03760262492919 - PAL250 Pressure feeler 250g: 2024-05-03 The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin a
• 03760262492926 - PAL400 Pressure feeler 400g: 2024-05-03 The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin a
• 03760262492933 - PAL650 Pressure feeler 650g: 2024-05-03 The Palpeur is a device for pressure applying. The pressure feeler is intended to produce stimulation of reflex points or skin a
• 03760262490427 - ASP: 2021-10-20 The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on t
• 03760262490465 - ASP: 2021-10-20 The ASP Original, Semi-Permanent Needle, is an original device allowing a small 2 mm needle to be implanted into the points on t