Sim.LED 8000 SC 5p Touch

GUDID 04250613846564

Sim.LED 8000 Single Color 5pole Touch

S.I.M.E.O.N. Medical GmbH & Co. KG

Operating room light

• Primary Device ID: 04250613846564
• NIH Device Record Key: 42a65824-b87a-421c-ab8d-766b8e053ae1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sim.LED 8000 SC 5p Touch
• Version Model Number: 141-0019585
• Company DUNS: 344838128
• Company Name: S.I.M.E.O.N. Medical GmbH & Co. KG
• 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	04250613846564 [Primary]

FDA Product Code

• FSY: Light, Surgical, Ceiling Mounted

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: 2024-01-26
• Device Publish Date: 2024-01-18

Devices Manufactured by S.I.M.E.O.N. Medical GmbH & Co. KG

• 04250613849282 - DM MS Sim.LED ExL DE: 2024-09-24
• 04250613849305 - MS Sim.LED OpL wSB: 2024-09-24
• 04250613849329 - MS Sim.LED OpL wDB: 2024-09-24
• 04250613849367 - MS Sim.LED OpL US: 2024-09-24
• 04250613849404 - DM MS Sim.LED ExL wSB: 2024-09-24
• 04250613846502 - Sim.LED 8000 SC 3p: 2024-02-23 Sim.LED 8000 Single Color 3pole
• 04250613846519 - Sim.LED 8000 MC 3p LC Touch: 2024-02-13 Sim.LED 8000 Multi Color 3pole Low Ceiling Touch
• 04250613846526 - Sim.LED 8000 MC 5p LC Touch: 2024-02-13 Sim.LED 8000 Multi Color 5pole Low Ceiling Touch