Portable Red LED Light Source

GUDID 00857326005581

LED light source, red

ENTELLUS MEDICAL, INC.

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• Primary Device ID: 00857326005581
• NIH Device Record Key: f117eac5-66d0-4c75-9d0f-f2a7c45095cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portable Red LED Light Source
• Version Model Number: PRLS-100
• Company DUNS: 017283879
• Company Name: ENTELLUS MEDICAL, INC.
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857326005581 [Primary]
GS1	10857326005588 [Package]; Package: Shelf Box [1 Units]; In Commercial Distribution

FDA Product Code

• NTN: Led Light Source

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-07-07
• Device Publish Date: 2020-09-18

Devices Manufactured by ENTELLUS MEDICAL, INC.

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• 00850002250268 - TGS: 2023-07-07 Universal Headrest Adapter B
• 00850002250275 - TGS: 2023-07-07 Universal Headrest Adapter C
• 00857326005567 - FocESS: 2023-07-07 HD Wireless Camera
• 00857326005581 - Portable Red LED Light Source: 2023-07-07LED light source, red
• 00857326005581 - Portable Red LED Light Source: 2023-07-07 LED light source, red
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