FDA UDI
In Commercial Distribution
🇺🇸 United States
ESPIRE
DI: 05056394327372
·
Model: Espire Elbow Hybrid- Left- Jet Black- Medial Dial- Small- COAPT
·
HUGH STEEPER LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ESPIRE
- Primary DI
- 05056394327372
- Version / Model
- Espire Elbow Hybrid- Left- Jet Black- Medial Dial- Small- COAPT
- Catalog Number
- EEH-LJMS-CO
- Company Name
- HUGH STEEPER LIMITED
- Labeler DUNS
- 210280350
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-29
- Public Version
- 1
- Public Version Date
- 2023-07-07
- Public Version Status
- New
- Public Device Record Key
- 0dac3a0f-7757-4944-b430-ed0c2d4770da
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| IRE | Joint, Elbow, External Limb Component, Powered | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41099 | Electrical elbow prosthesis | An artificial substitute for a missing elbow used as part of an upper-limb external prosthetic system and designed to restore some of the function of the joint. The device moves as the result of external motor power applied directly or via a connection with another functional limb component. The control of the device is achieved by an electromechanical switch for the motor that is operated by body movement using straps or cables. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05056394327372 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K182757 | 000 |