Primary Device ID | 00810832031567 |
NIH Device Record Key | f9effc4b-a955-459b-9efc-5419568b128b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Lantern Surgical Assistant (LSA) |
Version Model Number | 406000-02 |
Catalog Number | 406000-02 |
Company DUNS | 023266163 |
Company Name | ORTHALIGN, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Handling Environment Temperature | Between -22 Degrees Fahrenheit and 140 Degrees Fahrenheit |
00810832031406 | Lantern Knee Instrument Set |
00810832031444 | Packaged Assembly, Navigation Unit, LSA Knee |
00810832031567 | Packaged Assembly, Nav Unit, LSA |
00810832031543 | Drill Guide, Balance, LSA |
00810832031536 | Calibration Bracket, Balance, LSA |
00810832031512 | Torque Driver, 30 in-lbs |
00810832031505 | Torque Driver, 25 in-lbs |
00810832031499 | 10 X 10, Tray Base, Balance, LSA |
00810832031482 | Femoral Paddle Instrument, Balance, LSA |
00810832031475 | Tibial Paddle Instrument, Balance, LSA |
00810832031321 | Lantern Balance Instrument Set |
00810832031963 | Packaged Assembly, Nav Unit, LSA (JP) |
00810832031703 | Packaged Assembly, Nav Unit, LSA (EU) |
00810832032007 | Reference Sensor (RS), LSA (JP) |