Integra®

GUDID M57700MLX1

MLX 300W XENON LIGHTSOURCE

INTEGRA LIFESCIENCES (IRELAND) LIMITED

General-purpose light source

• Primary Device ID: M57700MLX1
• NIH Device Record Key: 7bcea7bc-4903-4b2a-b6b1-bec823d4ca86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: 00MLX
• Company DUNS: 989925396
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• 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: 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)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com
• Phone: +1(800)654-2873
• Email: custsvcnj@integralife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing
• Special Storage Condition, Specify: Between 0 and 0 *Storage Temperature: 0 C to 50 C (32 F to 122 F) Operating Temperature: 10 C to 40 C (50 F to 104 F) Humidity: 10 - 85% non-condensing

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780168140 [Primary]
HIBCC	M57700MLX1 [Secondary]

FDA Product Code

• FCW: Light source, fiberoptic, routine

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-13
• Device Publish Date: 2016-09-07

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• 10381780039938: Flexible EEG Cable Two-Piece, 10 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039921: Flexible EEG Cable Two-Piece, 02 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039914: Flexible EEG Cable Two-Piece, 48 Pins, 3 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039907: Flexible EEG Cable Two-Piece, 24 Pins, 2 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039891: Flexible EEG Cable Two-Piece, 32 Pins, 2 Cam Lock Connector. The Integra® Flexible EEG Cables a
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• 10381780039853: Flexible EEG Cable Two-Piece, 12 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039846: Flexible EEG Cable Two-Piece, 06 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Cables a
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• 10381780039822: Flexible EEG Round Cable Two-Piece, 04 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Ca
• 10381780121893: Use only Integra-supplied 14.4 V lithium ion battery for LICOX and CAMINO monitors. Charge time