Primary Device ID | 05690977432604 |
NIH Device Record Key | e270d94d-7d98-4734-8792-77710288302c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Symbionic Leg |
Version Model Number | SMBU2243 |
Catalog Number | SMBU2243 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 05690977432604 [Primary] |
ISW | ASSEMBLY, KNEE/SHANK/ANKLE/FOOT, EXTERNAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-06-18 |
Device Publish Date | 2018-05-16 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() SYMBIONIC LEG 85409577 not registered Dead/Abandoned |
Ossur hf 2011-08-29 |