Primary Device ID | 00818806020715 |
NIH Device Record Key | dacc021f-66b6-4e82-9d08-26d0ec86fae6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RxSight Light Adjustable Lens (RxLAL) |
Version Model Number | 60005-3220 |
Company DUNS | 052054413 |
Company Name | RXSIGHT, 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 | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
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 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00818806020715 [Primary] |
PZK | Light Adjustable Lens (Lal) And Light Delivery Device (Ldd) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-06-23 |
Device Publish Date | 2021-06-15 |
00818806020319 | LAL, Sterile, Packaged, 30.0 Diopter |
00818806020302 | LAL, Sterile, Packaged, 29.0 Diopter |
00818806020296 | LAL, Sterile, Packaged, 28.0 Diopter |
00818806020289 | LAL, Sterile, Packaged, 27.0 Diopter |
00818806020272 | LAL, Sterile, Packaged, 26.0 Diopter |
00818806020265 | LAL, Sterile, Packaged, 25.0 Diopter |
00818806020258 | LAL, Sterile, Packaged, 24.0 Diopter |
00818806020241 | LAL, Sterile, Packaged, 23.5 Diopter |
00818806020234 | LAL, Sterile, Packaged, 23.0 Diopter |
00818806020227 | LAL, Sterile, Packaged, 22.5 Diopter |
00818806020210 | LAL, Sterile, Packaged, 22.0 Diopter |
00818806020203 | LAL, Sterile, Packaged, 21.5 Diopter |
00818806020197 | LAL, Sterile, Packaged, 21.0 Diopter |
00818806020180 | LAL, Sterile, Packaged, 20.5 Diopter |
00818806020173 | LAL, Sterile, Packaged, 20.0 Diopter |
00818806020166 | LAL, Sterile, Packaged, 19.5 Diopter |
00818806020159 | LAL, Sterile, Packaged, 19.0 Diopter |
00818806020142 | LAL, Sterile, Packaged, 18.5 Diopter |
00818806020135 | LAL, Sterile, Packaged, 18.0 Diopter |
00818806020128 | LAL, Sterile, Packaged, 17.5 Diopter |
00818806020111 | LAL, Sterile, Packaged, 17.0 Diopter |
00818806020104 | LAL, Sterile, Packaged, 16.5 Diopter |
00818806020098 | LAL, Sterile, Packaged, 16.0 Diopter |
00818806020081 | LAL, Sterile, Packaged, 15.0 Diopter |
00818806020074 | LAL, Sterile, Packaged, 14.0 Diopter |
00818806020067 | LAL, Sterile, Packaged, 13.0 Diopter |
00818806020050 | LAL, Sterile, Packaged, 12.0 Diopter |
00818806020043 | LAL, Sterile, Packaged, 11.0 Diopter |
00818806020036 | LAL, Sterile, Packaged, 10.0 Diopter |
00818806020944 | LAL, Sterile, Packaged, 9.0 Diopter |
00818806020937 | LAL, Sterile, Packaged, 8.0 Diopter |
00818806020920 | LAL, Sterile, Packaged, 7.0 Diopter |
00818806020913 | LAL, Sterile, Packaged, 6.0 Diopter |
00818806020906 | LAL, Sterile, Packaged, 5.0 Diopter |
00818806020890 | LAL, Sterile, Packaged, 4.0 Diopter |
00818806020821 | LAL, Sterile, Packaged, 16.0 Diopter |
00818806020814 | LAL, Sterile, Packaged, 30.0 Diopter |
00818806020807 | LAL, Sterile, Packaged, 29.0 Diopter |
00818806020791 | LAL, Sterile, Packaged, 28.0 Diopter |
00818806020784 | LAL, Sterile, Packaged, 27.0 Diopter |
00818806020777 | LAL, Sterile, Packaged, 26.0 Diopter |
00818806020760 | LAL, Sterile, Packaged, 25.0 Diopter |
00818806020753 | LAL, Sterile, Packaged, 24.0 Diopter |
00818806020746 | LAL, Sterile, Packaged, 23.5 Diopter |
00818806020739 | LAL, Sterile, Packaged, 23.0 Diopter |
00818806020722 | LAL, Sterile, Packaged, 22.5 Diopter |
00818806020715 | LAL, Sterile, Packaged, 22.0 Diopter |
00818806020708 | LAL, Sterile, Packaged, 21.5 Diopter |
00818806020692 | LAL, Sterile, Packaged, 21.0 Diopter |
00818806020685 | LAL, Sterile, Packaged, 20.5 Diopter |