Identity
- Trade Name
- Luke Replaceable Part FDA UDI
- Generic Name
- Myoelectric hand prosthesis FDA UDI
- Device Name
- CONVENIENCE KIT, GLOVE, RIGHT Includes: LU-38012-001 GLOVE, RIGHT 00859503006299 LU-41091-001 STRING, GLOVE 00859503006695 FDA UDI
- Model / Reference
- LU-12011-001 FDA UDI
- Description
- CONVENIENCE KIT, GLOVE, RIGHT Includes: LU-38012-001 GLOVE, RIGHT 00859503006299 LU-41091-001 STRING, GLOVE 00859503006695 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859503006671 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
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
DEN120016 also covers:
- LUKE Arm — MOBIUS BIONICS LLC
- LUKE Arm — MOBIUS BIONICS LLC
- LUKE Arm — MOBIUS BIONICS LLC
- LUKE Arm — MOBIUS BIONICS LLC
- LUKE Arm — MOBIUS BIONICS LLC
- LUKE Arm — MOBIUS BIONICS LLC
- Luke Replaceable Part — MOBIUS BIONICS LLC
- Luke Replaceable Part — MOBIUS BIONICS LLC
- Luke Replaceable Part — MOBIUS BIONICS LLC
- Luke Replaceable Part — MOBIUS BIONICS LLC
- Luke Replaceable Part — MOBIUS BIONICS LLC
- Luke Replaceable Part — MOBIUS BIONICS LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mobius Bionics Llc
Sources (1)
- FDA UDI 26f5282a-385b-47a3-9351-444310f5f09c 34 fields · synced May 30, 2026