FDA UDI
In Commercial Distribution
🇺🇸 United States
Rheo Knee
DI: 05690977467804
·
Model: RKNXC0003
·
OSSUR AMERICAS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rheo Knee
- Primary DI
- 05690977467804
- Version / Model
- RKNXC0003
- Catalog Number
- RKNXC0003
- Company Name
- OSSUR AMERICAS, INC.
- Labeler DUNS
- 139280028
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 1
- Public Version Date
- 2018-06-18
- Public Version Status
- New
- Public Device Record Key
- 9278c842-8de5-44c0-9633-986621502d7d
Device Description
RHEO KNEE XC 3 YRS WARRANTY
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
- 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 |
|---|---|---|---|---|
| ISW | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL | Physical Medicine | 890.3500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41541 | Knee-disarticulation prosthesis | An artificial substitute for a disarticulation amputation at the knee joint, or used in cases of limb deficiency at birth, designed as a component of an external lower-limb prosthesis to restore some of the appearance and/or function of the normal anatomy. It is typically made of metal and plastic and is typically constructed as a polycentric hinge that incorporates an upper joint section that fits against a full-length prosthetic femur. It is typically spring-assisted to control the swing of the leg. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05690977467804 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 100 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 45 Degrees Celsius