Primary Device ID | 00841542102926 |
NIH Device Record Key | 99a3f05f-de2f-49ea-b931-abd6e73b238d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Visian ICL (Implantable Collamer Lens) |
Version Model Number | MICL 12.6 |
Company DUNS | 054751110 |
Company Name | STAAR SURGICAL COMPANY |
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 | false |
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 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00841542102926 [Primary] |
MTA | Lens, Intraocular, Phakic |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-20 |
00841542103688 | Diopter: -16.0; Overall Diameter (Length): 13.7 mm |
00841542103671 | Diopter: -15.5; Overall Diameter (Length): 13.7 mm |
00841542103664 | Diopter: -15.0; Overall Diameter (Length): 13.7 mm |
00841542103657 | Diopter: -14.5; Overall Diameter (Length): 13.7 mm |
00841542103640 | Diopter: -14.0; Overall Diameter (Length): 13.7 mm |
00841542103633 | Diopter: -13.5; Overall Diameter (Length): 13.7 mm |
00841542103626 | Diopter: -13.0; Overall Diameter (Length): 13.7 mm |
00841542103619 | Diopter: -12.5; Overall Diameter (Length): 13.7 mm |
00841542103602 | Diopter: -12.0; Overall Diameter (Length): 13.7 mm |
00841542103596 | Diopter: -11.5; Overall Diameter (Length): 13.7 mm |
00841542103589 | Diopter: -11.0; Overall Diameter (Length): 13.7 mm |
00841542103572 | Diopter: -10.5; Overall Diameter (Length): 13.7 mm |
00841542103565 | Diopter: -10.0; Overall Diameter (Length): 13.7 mm |
00841542103558 | Diopter: -9.5; Overall Diameter (Length): 13.7 mm |
00841542103541 | Diopter: -9.0; Overall Diameter (Length): 13.7 mm |
00841542103534 | Diopter: -8.5; Overall Diameter (Length): 13.7 mm |
00841542103527 | Diopter: -8.0; Overall Diameter (Length): 13.7 mm |
00841542103510 | Diopter: -7.5; Overall Diameter (Length): 13.7 mm |
00841542103503 | Diopter: -7.0; Overall Diameter (Length): 13.7 mm |
00841542103497 | Diopter: -6.5; Overall Diameter (Length): 13.7 mm |
00841542103480 | Diopter: -6.0; Overall Diameter (Length): 13.7 mm |
00841542103473 | Diopter: -5.5; Overall Diameter (Length): 13.7 mm |
00841542103466 | Diopter: -5.0; Overall Diameter (Length): 13.7 mm |
00841542103459 | Diopter: -4.5; Overall Diameter (Length): 13.7 mm |
00841542103442 | Diopter: -4.0; Overall Diameter (Length): 13.7 mm |
00841542103435 | Diopter: -3.5; Overall Diameter (Length): 13.7 mm |
00841542103428 | Diopter: -3.0; Overall Diameter (Length): 13.7 mm |
00841542103411 | Diopter: -16.0; Overall Diameter (Length): 13.2 mm |
00841542103404 | Diopter: -15.5; Overall Diameter (Length): 13.2 mm |
00841542103398 | Diopter: -15.0; Overall Diameter (Length): 13.2 mm |
00841542103381 | Diopter: -14.5; Overall Diameter (Length): 13.2 mm |
00841542103374 | Diopter: -14.0; Overall Diameter (Length): 13.2 mm |
00841542103367 | Diopter: -13.5; Overall Diameter (Length): 13.2 mm |
00841542103350 | Diopter: -13.0; Overall Diameter (Length): 13.2 mm |
00841542103343 | Diopter: -12.5; Overall Diameter (Length): 13.2 mm |
00841542103336 | Diopter: -12.0; Overall Diameter (Length): 13.2 mm |
00841542103329 | Diopter: -11.5; Overall Diameter (Length): 13.2 mm |
00841542103312 | Diopter: -11.0; Overall Diameter (Length): 13.2 mm |
00841542103305 | Diopter: -10.5; Overall Diameter (Length): 13.2 mm |
00841542103299 | Diopter: -10.0; Overall Diameter (Length): 13.2 mm |
00841542103282 | Diopter: -9.5; Overall Diameter (Length): 13.2 mm |
00841542103275 | Diopter: -9.0; Overall Diameter (Length): 13.2 mm |
00841542103268 | Diopter: -8.5; Overall Diameter (Length): 13.2 mm |
00841542103251 | Diopter: -8.0; Overall Diameter (Length): 13.2 mm |
00841542103244 | Diopter: -7.5; Overall Diameter (Length): 13.2 mm |
00841542103237 | Diopter: -7.0; Overall Diameter (Length): 13.2 mm |
00841542103220 | Diopter: -6.5; Overall Diameter (Length): 13.2 mm |
00841542103213 | Diopter: -6.0; Overall Diameter (Length): 13.2 mm |
00841542103206 | Diopter: -5.5; Overall Diameter (Length): 13.2 mm |
00841542103190 | Diopter: -5.0; Overall Diameter (Length): 13.2 mm |