Luke Replaceable Part

FDA UDI

Class II (US FDA UDI)

by Mobius Bionics Llc

Identity

Trade Name: Luke Replaceable Part FDA UDI
Generic Name: Myoelectric hand prosthesis FDA UDI
Device Name: CONVENIENCE KIT, FINGERNAILS AND SCREWS Includes: LU-41115-001 Recloseable Bag, 1.5" x 2" 2MIL DKLU-41005-20060 SCREW, CHEESE HEAD, MACHINE (SLOTTED), M2.0 X 0.40 X 6MM STAINLESS STEEL 8 (qty. 8) DKLU-41005-20050 SCREW, CHEESE HEAD, MACHINE (SLOTTED), M2.0 X 0.40 X 5MM STAINLESS STEEL 2 (qty. 2) DKLU-36352-001 FINGERNAIL, THUMB DKLU-36403-001 FINGERNAIL, PINKY DKLU-36407-001 FINGERNAIL, MIDDLE AND RING FINGERS DKLU-36434-001 FINGERNAIL, INDEX FDA UDI
Model / Reference: LU-12010-001 FDA UDI
Description: CONVENIENCE KIT, FINGERNAILS AND SCREWS Includes: LU-41115-001 Recloseable Bag, 1.5" x 2" 2MIL DKLU-41005-20060 SCREW, CHEESE HEAD, MACHINE (SLOTTED), M2.0 X 0.40 X 6MM STAINLESS STEEL 8 (qty. 8) DKLU-41005-20050 SCREW, CHEESE HEAD, MACHINE (SLOTTED), M2.0 X 0.40 X 5MM STAINLESS STEEL 2 (qty. 2) DKLU-36352-001 FINGERNAIL, THUMB DKLU-36403-001 FINGERNAIL, PINKY DKLU-36407-001 FINGERNAIL, MIDDLE AND RING FINGERS DKLU-36434-001 FINGERNAIL, INDEX FDA UDI

Identifiers

Primary DI / UDI-DI: 00859503006220 FDA UDI
510(k) Number: DEN120016 FDA UDI
FDA Product Code: PAE FDA UDI
GMDN Term: Myoelectric hand prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.3450 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Myoelectric hand prosthesis

Luke Replaceable Part by Mobius Bionics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Myoelectric hand prosthesis.

Remote Electrode — Otto Bock Healthcare Products GmbH · Class II
Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
S-CHARGE — HUGH STEEPER LIMITED · Class I
Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
BATTERY SYSTEM — HUGH STEEPER LIMITED · Class I
Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II
Remote Electrode — Otto Bock Healthcare Products GmbH · Class II
Sense System with IBT Electrodes — Infinite Biomedical Technologies LLC · Class II

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Mobius Bionics Llc

Sources (1)

FDA UDI d2e8e42d-90a8-4c5b-9d36-71b632985633 34 fields · synced Jun 8, 2026