FDA UDI
In Commercial Distribution
🇺🇸 United States
Paseo Knee
DI: 00850013242306
·
Model: CA602-ML
·
CYPRESS ADAPTIVE, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Paseo Knee
- Primary DI
- 00850013242306
- Version / Model
- CA602-ML
- Catalog Number
- CA602-ML
- 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
- e8d80117-303b-4872-96ca-904a923bec50
Device Description
MONOCENTRIC BRAKE KNEE JOINT WITH STANCE FLEXION AND MANUAL LOCK
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 |
|---|---|---|---|---|
| 58962 | Single-axis stabilizing knee prosthesis | An artificial substitute for a transfemoral (above-the-knee) amputation designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It typically consists of metal and plastic and is constructed as a single-axis, mechanical hinge that incorporates adjustable swing and weight activated stance control. It may also be known as a single-axis friction knee. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850013242306 | GS1 |