FDA UDI
In Commercial Distribution
🇺🇸 United States
Transtibial Exhaust Valve active.valve
DI: 04048817574976
·
Model: 6P50
·
Streifeneder ortho.production GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Transtibial Exhaust Valve active.valve
- Primary DI
- 04048817574976
- Version / Model
- 6P50
- Catalog Number
- 6P50
- Company Name
- Streifeneder ortho.production GmbH
- Labeler DUNS
- 317931954
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-04
- Public Version
- 1
- Public Version Date
- 2020-11-12
- Public Version Status
- New
- Public Device Record Key
- e0380f7a-187e-485d-a2da-3d012d9c92e2
Device Description
Transtibial Exhaust Valve active.valve, to secure the prosthesis within the socket by vacuum, Aluminium
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
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ISP | Valve, Prosthesis | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64715 | External lower-limb prosthesis suspensory component, non-powered | A non-powered device intended to be integrated in the socket shell of an external lower limb prosthesis to reduce the axial movement between the residual limb and the prosthesis, when the prosthesis is unloaded. It may be designed in various forms (e.g., strap, sleeve, cuff, thigh corset, shell, belt, pin, lock, valves). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048817574976 | GS1 |