Luke Replaceable Part

GUDID 00859503006121

ASSY, ACI

MOBIUS BIONICS LLC

Myoelectric hand prosthesis

• Primary Device ID: 00859503006121
• NIH Device Record Key: c474e07f-0720-4b58-9314-04f9000b5af1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luke Replaceable Part
• Version Model Number: LU-20264-001
• Company DUNS: 080216821
• Company Name: MOBIUS BIONICS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859503006121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN120016

FDA Product Code

• PAE: Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography

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: 2018-07-06
• Device Publish Date: 2016-10-21

On-Brand Devices [Luke Replaceable Part]

• 00859503006725: ADAPTER, TR SOCKET, COARSE
• 00859503006695: STRING, GLOVE
• 00859503006688: CONVENIENCE KIT, GLOVE, LEFT Includes: LU-38012-002 GLOVE, LEFT 00859503006305 LU-41091-001 S
• 00859503006671: CONVENIENCE KIT, GLOVE, RIGHT Includes: LU-38012-001 GLOVE, RIGHT 00859503006299 LU-41091-001
• 00859503006664: ASSY, PRESSURE TRANSDUCER, 500 MM
• 00859503006657: ASSY, PRESSURE TRANSDUCER, 350 MM
• 00859503006640: ASSY, PRESSURE TRANSDUCER, 200 MM
• 00859503006633: WRENCH, SPANNER
• 00859503006626: CHARGER, IMU, DUAL QI
• 00859503006619: CABLE, MICRO USB
• 00859503006602: LINE CORD, AC ADAPTER
• 00859503006596: AC ADAPTER
• 00859503006589: BATTERY, EXTERNAL
• 00859503006572: CABLE, RC POWER AND CAN, EXTERNAL, SHIELDED
• 00859503006565: CABLE, ACI STRAIGHT TO MOTION CONTROL BUMP SWITCH, 300 MM
• 00859503006558: CABLE, ACI STRAIGHT TO MOTION CONTROL BUMP SWITCH, 150 MM
• 00859503006541: CABLE, ACI STRAIGHT TO OTTO BOCK 9E185, 2CH, 300 MM
• 00859503006534: CABLE, ACI STRAIGHT TO OTTO BOCK 9E185, 2CH, 150 MM
• 00859503006527: CABLE, ACI STRAIGHT TO OTTO BOCK 9E185, 1CH, 300 MM
• 00859503006510: CABLE, ACI STRAIGHT TO OTTO BOCK 9E185, 1CH, 150 MM
• 00859503006503: CABLE, ACI STRAIGHT TO FLAT RIBBON
• 00859503006497: CABLE, EXTERNAL BATTERY EXTENSION, 1000 MM
• 00859503006480: CABLE, EXTERNAL BATTERY EXTENSION, 500 MM
• 00859503006473: CABLE, ACI & TACTOR EXTENSION, 500 MM
• 00859503006466: CABLE, ACI & TACTOR EXTENSION, 350 MM
• 00859503006459: CABLE, ACI & TACTOR EXTENSION, 200 MM
• 00859503006442: SCREW, FINGER NAIL
• 00859503006435: RC EXTERNAL BATTERY ADAPTER MOCKUP
• 00859503006428: HOLDER, TACTOR, BELT
• 00859503006411: CLIP, TACTOR, SCREW
• 00859503006404: CLIP, IMU
• 00859503006398: HOLE PLUG, RC SOCKET ADAPTER
• 00859503006381: THREAD PROTECTOR, HC SOCKET ADAPTER
• 00859503006374: THREAD PROTECTOR, RC SOCKET ADAPTER
• 00859503006367: COT, PINKY FINGER
• 00859503006350: COT, RING FINGER
• 00859503006343: COT, MIDDLE FINGER
• 00859503006336: COT, INDEX FINGER
• 00859503006329: COT, THUMB, LEFT
• 00859503006312: COT, THUMB, RIGHT
• 00859503006305: GLOVE, LEFT
• 00859503006299: GLOVE, RIGHT
• 00859503006282: INTERFACE, SHOULDER CLAMP AND LAMINATION
• 00859503006275: SHOULDER MOUNT, BEND BRACKET
• 00859503006268: FINGER NAIL, INDEX
• 00859503006251: FINGER NAIL, MIDDLE & RING
• 00859503006244: FINGER NAIL, PINKY
• 00859503006237: FINGER NAIL, THUMB
• 00859503006213: ASSY, RC EXTERNAL BATTERY ADAPTER
• 00859503006206: ASSY, FITTING ARM