FDA UDI
In Commercial Distribution
🇺🇸 United States
Luke Replaceable Part
DI: 00859503006367
·
Model: LU-38017-001
·
MOBIUS BIONICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Luke Replaceable Part
- Primary DI
- 00859503006367
- Version / Model
- LU-38017-001
- Company Name
- MOBIUS BIONICS LLC
- Labeler DUNS
- 080216821
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-21
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 025301e7-8ba3-496f-91ea-c68d5c2eb7e0
Device Description
COT, PINKY FINGER
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PAE | Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography | Physical Medicine | 890.3450 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41497 | Myoelectric hand prosthesis | A powered artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to replace the appearance and some of the function of the hand. The device moves as the result of a motor(s) that may be integral or proximally mounted with a mechanical link. The control of movement is achieved through amplified muscle action potentials from voluntary contracting muscle in the residual limb/trunk, transmitted via surface electrodes in the device that make contact with the skin, which turn on the motor to provide a function. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00859503006367 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN120016 | 000 |