Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26) MV2S

GUDID 03665415002284

LAMIDEY NOURY MEDICAL

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• Primary Device ID: 03665415002284
• NIH Device Record Key: 5b1764e6-e961-4be8-8be7-aef22752b02c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26)
• Version Model Number: MV2S
• Catalog Number: MV2S
• Company DUNS: 266955967
• Company Name: LAMIDEY NOURY MEDICAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr
• Phone: +33169206969
• Email: info@lamidey-noury.fr

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	03665415002277 [Primary]
GS1	03665415002284 [Package]; Contains: 03665415002277; Package: Boxes [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213135

FDA Product Code

• FAS: Electrode, Electrosurgical, Active, Urological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-01
• Device Publish Date: 2023-04-21

Devices Manufactured by LAMIDEY NOURY MEDICAL

• 03665415002116 - Electrosurgical Unit MCB: 2023-05-01
• 03665415002154 - Active working element (SIDE load; round ; Fr26 ; OLYMPUS compatible): 2023-05-01
• 03665415002161 - Passive working element (SIDE load; round ; Fr26 ; OLYMPUS compatible): 2023-05-01
• 03665415002178 - Active working element (SIDE load; round ; Fr26 ; STORZ compatible): 2023-05-01
• 03665415002185 - Passive working element (SIDE load; round ; Fr26 ; STORZ compatible): 2023-05-01
• 03665415002260 - Bipolar electrode / VAPORIZATION (SIDE load; round fitting ; Fr26): 2023-05-01
• 03665415002284 - Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26): 2023-05-01
• 03665415002284 - Bipolar cutting loop / THICK (SIDE load; round fitting ; Fr26): 2023-05-01
• 03665415002307 - Bipolar cutting loop / THIN (SIDE load; round fitting ; Fr26): 2023-05-01