IM4000E

GUDID 30845854041844

HIGH DEFINITION CAMERA CONTROLLER (ECONOMY)

Conmed Corporation

Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera Endoscope video camera

• Primary Device ID: 30845854041844
• NIH Device Record Key: bde051a4-5f43-40cf-adb0-e5c958f237c4
• Commercial Distribution Discontinuation: 2022-06-25
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: IM4000E
• Catalog Number: IM4000E
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *500 - 1060 Storage Environment Atmospheric Pressure
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10845854041840 [Primary]
GS1	30845854041844 [Direct Marking]

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2022-06-27
• Device Publish Date: 2016-09-24

Devices Manufactured by Conmed Corporation

• 30845854026797 - GENESYS CrossFT, Hi-Fi: 2024-04-25 5.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
• 30845854026803 - GENESYS CrossFT, Hi-Fi: 2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Two #2 (5 metric) Hi-Fi Sutures
• 30845854026810 - GENESYS CrossFT, Hi-Fi: 2024-04-25 6.5 mm GENESYS CrossFT Suture Anchor with Three #2 (5 metric) Hi-Fi Sutures
• 30845854027862 - GENESYS PressFT, Hi-Fi: 2024-04-25 GENESYS PressFT 2.1 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
• 30845854027893 - GENESYS PressFT, Hi-Fi: 2024-04-25 GENESYS PressFT 2.6 w/One #2 (5 metric) Hi-Fi Suture, HIP (1 White/Black)
• 30845854034600 - GENESYS CrossFT, Hi-Fi: 2024-04-25 GENESYS CrossFT 5.5 mm Suture Anchor, w/3 Hi-Fi #2 (5 metric) Sutures w/Needles
• 30845854034617 - GENESYS CrossFT, Hi-Fi: 2024-04-25 GENESYS CrossFT 6.5 mm Suture Anchor, w/2 Hi-Fi #2 (5 metric) Sutures w/Needles
• 30653405988643 - Argo Knotless GENESYS: 2024-04-22 5.5mm Argo Knotless® GENESYSTM Anchor