Symbionic Leg SMBU7263
GUDID 05690977432994
KIT SYMBIONIC 3 UNITY C7S263Y
OSSUR AMERICAS, INC.
Dynamic-response foot prosthesis| Primary Device ID | 05690977432994 |
| NIH Device Record Key | 37bdad1d-53f1-4017-8bfc-27ee2bd0d64d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Symbionic Leg |
| Version Model Number | SMBU7263 |
| Catalog Number | SMBU7263 |
| 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
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between -10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05690977432994 [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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