FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Symbionic Leg
DI: 05690977433045
·
Model: SMBU8253
·
OSSUR AMERICAS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Symbionic Leg
- Primary DI
- 05690977433045
- Version / Model
- SMBU8253
- Catalog Number
- SMBU8253
- Company Name
- OSSUR AMERICAS, INC.
- Labeler DUNS
- 139280028
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-16
- Public Version
- 2
- Public Version Date
- 2021-03-09
- Public Version Status
- Update
- Public Device Record Key
- 9b43d3e9-a545-4940-a18c-d873e917ad03
- Distribution End Date
- 2018-07-31
Device Description
KIT SYMBIONIC 3 UNITY C8S253Y
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 |
|---|---|---|---|---|
| 64721 | Mechatronic external knee prosthesis | A battery-powered electromechanical device which is a component of an external lower limb prosthesis designed to functionally replace, in part or total, an absent knee, wherein the principle of operation for motion control is based on hydraulic, pneumatic, or magnetorheological actuation regulated by a motion-feedback mechanism using electronic sensors and software. It is intended to respond to changes in motion in real-time by continuously sensing knee flexion speed and temperature and instantly adjusting motion resistance within a single step. Known as a microprocessor-controlled knee (MPK), it may have various designs and functional features for support during a variety of activities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05690977433045 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 45 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity