FDA UDI
In Commercial Distribution
🇺🇸 United States
Vista Ankle
DI: 00850013242283
·
Model: CA500-BMP
·
CYPRESS ADAPTIVE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Vista Ankle
- Primary DI
- 00850013242283
- Version / Model
- CA500-BMP
- Catalog Number
- CA500-BMP
- Company Name
- CYPRESS ADAPTIVE, LLC
- Labeler DUNS
- 080277500
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-02
- Public Version
- 1
- Public Version Date
- 2019-12-10
- Public Version Status
- New
- Public Device Record Key
- 76548607-3b66-4e21-a0dc-775e28f8d675
Device Description
a universal single axis prosthetic ankle for elevated vacuum suspension
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
- 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 |
|---|---|---|---|---|
| ISY | Joint, Knee, External Limb Component | Physical Medicine | 890.3420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41537 | Ankle-disarticulation prosthesis | An artificial substitute for part of the lower limb after amputation at the ankle joint used to restore some of the appearance and/or function of the normal anatomy. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850013242283 | GS1 |