Integra®

GUDID M433AX1375BIF1

Ancillary, HeadBand Ultra Lite Plus BIF

INTEGRA LIFESCIENCES (IRELAND) LIMITED

General-purpose light source

• Primary Device ID: M433AX1375BIF1
• NIH Device Record Key: afde2036-f3aa-4440-9f79-1b659f48d1ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Integra®
• Version Model Number: AX1375BIF
• Company DUNS: 989925396
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• 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: true
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10381780168836 [Primary]
HIBCC	M433AX1375BIF1 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K864380

FDA Product Code

• FST: LIGHT, SURGICAL, FIBEROPTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-03-13
• Device Publish Date: 2016-08-31

On-Brand Devices [Integra®]

• 10381780356646: DLX Power Supply
• 10381780356622: Fixed Focus Headlight Camera System (NTSC) (US)
• 10381780356561: Fixed Focus Headlight Camera System Mounting Bracket
• H8346009600: Assembly, Cable S-Video 25 foot, Male/Male Connectors
• M433AX2100BIF1: ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE
• M433AX1385BIF1: Ancillary, SweatBand Ultra Lite Plus BIF
• M433AX1375BIF1: Ancillary, HeadBand Ultra Lite Plus BIF
• M43390012PX1: COAXIAL HEADLIGHT JOYSTICK
• H8346022321: Caster, Black, no brake
• H8346009871: Fuse, 6.3AMP, Slow Blow
• M4334074811: POWER SUPPLY, 60W, PACKAGED
• M4334074211: POWER SUPPLY, 30W, PACKAGED
• M57700MLX1: MLX 300W XENON LIGHTSOURCE
• M433005331LX1: Clip, Latching Cable
• M433001775LX1: Duffle Bag, Nylon, Ancillary System
• M405001388LX91: Premium Headlight Cable, Ultralite Pro
• M405001388LX111: Premium Headlight Cable, Ultralite Pro
• M433001387LX1: ULTRALITE PRO PAD REPLACEMENT KIT
• M433001380LX1: Headlight Module, Ultralite Pro
• M433001370LX1: ULTRALITE PRO REPLACEMENT HEADBAND
• M4330013371: Floorstand, MLX
• M4330013281: Mark II Module, Gray
• M433001320LX1: Complete Lamp Module, MLX
• M433001290BIFREP1: Sweatband for Bifurcated Cable, Ultralite Plus
• M433001290BIF01: Sweatband Only, Ultralite Plus
• M433001270BIF1: Headband Only, Ultralite Plus
• M433001170BIF1: ASSY, HEADBAND ULTRALITE BIFUR
• H8346022311: Caster, Black, with brake
• M4334003551: Extended Linkage Kit, All Modules
• M433400282LX1: Headband Pad Replacement Kit, Ultralite Plus
• M433004810LX1: Gown Clips, All Headlights
• 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
• 10381780039884: Flexible EEG Cable Two-Piece, 64 Pins, 4 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039877: Flexible EEG Cable Two-Piece, 16 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 10381780039860: Flexible EEG Cable Two-Piece, 20 Pins, 2 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 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
• 10381780039839: Flexible EEG Cable Two-Piece, 08 Pins, 1 Cam Lock Connector. The Integra® Flexible EEG Cables a
• 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