Symbionic Leg SMBU7283
GUDID 05690977433014
KIT SYMBIONIC 3 UNITY C7S283Y
OSSUR AMERICAS, INC.
Dynamic-response foot prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis Mechatronic external knee prosthesis| Primary Device ID | 05690977433014 |
| NIH Device Record Key | f2eca1a3-8f0e-4615-b1b2-11db0e52e3f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symbionic Leg |
| Version Model Number | SMBU7283 |
| Catalog Number | SMBU7283 |
| Company DUNS | 139280028 |
| Company Name | OSSUR AMERICAS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05690977433014 [Primary] |
FDA Product Code
| ISW | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-06-18 |
| Device Publish Date | 2018-05-16 |
On-Brand Devices [Symbionic Leg]
| 05690977433090 | KIT SYMBIONIC 3 UNITY C8S303Y |
| 05690977433083 | KIT SYMBIONIC 3 UNITY C8S293Y |
| 05690977433076 | KIT SYMBIONIC 3 UNITY C8S283Y |
| 05690977433069 | KIT SYMBIONIC 3 UNITY C8S273Y |
| 05690977433052 | KIT SYMBIONIC 3 UNITY C8S263Y |
| 05690977433045 | KIT SYMBIONIC 3 UNITY C8S253Y |
| 05690977433038 | KIT SYMBIONIC 3 UNITY C7S303Y |
| 05690977433021 | KIT SYMBIONIC 3 UNITY C7S293Y |
| 05690977433014 | KIT SYMBIONIC 3 UNITY C7S283Y |
| 05690977433007 | KIT SYMBIONIC 3 UNITY C7S273Y |
| 05690977432994 | KIT SYMBIONIC 3 UNITY C7S263Y |
| 05690977432987 | KIT SYMBIONIC 3 UNITY C7S253Y |
| 05690977432970 | KIT SYMBIONIC 3 UNITY C6S303Y |
| 05690977432963 | KIT SYMBIONIC 3 UNITY C6S293Y |
| 05690977432956 | KIT SYMBIONIC 3 UNITY C6S283Y |
| 05690977432949 | KIT SYMBIONIC 3 UNITY C6S273Y |
| 05690977432932 | KIT SYMBIONIC 3 UNITY C6S263Y |
| 05690977432925 | KIT SYMBIONIC 3 UNITY C6S253Y |
| 05690977432918 | KIT SYMBIONIC 3 UNITY C5S303Y |
| 05690977432901 | KIT SYMBIONIC 3 UNITY C5S293Y |
| 05690977432895 | KIT SYMBIONIC 3 UNITY C5S283Y |
| 05690977432888 | KIT SYMBIONIC 3 UNITY C5S273Y |
| 05690977432871 | KIT SYMBIONIC 3 UNITY C5S263Y |
| 05690977432864 | KIT SYMBIONIC 3 UNITY C5S253Y |
| 05690977432857 | KIT SYMBIONIC 3 UNITY C5S243Y |
| 05690977432840 | KIT SYMBIONIC 3 UNITY C5S233Y |
| 05690977432833 | KIT SYMBIONIC 3 UNITY C5S223Y |
| 05690977432826 | KIT SYMBIONIC 3 UNITY C4S303Y |
| 05690977432819 | KIT SYMBIONIC 3 UNITY C4S293Y |
| 05690977432802 | KIT SYMBIONIC 3 UNITY C4S283Y |
| 05690977432796 | KIT SYMBIONIC 3 UNITY C4S273Y |
| 05690977432789 | KIT SYMBIONIC 3 UNITY C4S263Y |
| 05690977432772 | KIT SYMBIONIC 3 UNITY C4S253Y |
| 05690977432765 | KIT SYMBIONIC 3 UNITY C4S243Y |
| 05690977432758 | KIT SYMBIONIC 3 UNITY C4S233Y |
| 05690977432741 | KIT SYMBIONIC 3 UNITY C4S223Y |
| 05690977432734 | KIT SYMBIONIC 3 UNITY C3S303Y |
| 05690977432727 | KIT SYMBIONIC 3 UNITY C3S293Y |
| 05690977432710 | KIT SYMBIONIC 3 UNITY C3S283Y |
| 05690977432703 | KIT SYMBIONIC 3 UNITY C3S273Y |
| 05690977432697 | KIT SYMBIONIC 3 UNITY C3S263Y |
| 05690977432680 | KIT SYMBIONIC 3 UNITY C3S253Y |
| 05690977432673 | KIT SYMBIONIC 3 UNITY C3S243Y |
| 05690977432666 | KIT SYMBIONIC 3 UNITY C3S233Y |
| 05690977432659 | KIT SYMBIONIC 3 UNITY C3S223Y |
| 05690977432642 | KIT SYMBIONIC 3 UNITY C2S283Y |
| 05690977432635 | KIT SYMBIONIC 3 UNITY C2S273Y |
| 05690977432628 | KIT SYMBIONIC 3 UNITY C2S263Y |
| 05690977432611 | KIT SYMBIONIC 3 UNITY C2S253Y |
| 05690977432604 | KIT SYMBIONIC 3 UNITY C2S243Y |
Trademark Results [Symbionic Leg]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SYMBIONIC LEG 85409577 not registered Dead/Abandoned |
Ossur hf 2011-08-29 |
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