Primary Device ID | 08809447652511 |
NIH Device Record Key | a0793e2e-483a-4549-8b3f-9e73759ef086 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CLARITY II |
Version Model Number | FUSE |
Company DUNS | 688282516 |
Company Name | Lutronic Corporation |
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 | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
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 |
Phone | 408-912-1701 |
jasonkim@lutronic.com | |
Phone | 408-912-1701 |
jasonkim@lutronic.com | |
Phone | 408-912-1701 |
jasonkim@lutronic.com | |
Phone | 408-912-1701 |
jasonkim@lutronic.com | |
Phone | 408-912-1701 |
jasonkim@lutronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08809447652511 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2021-07-26 |
Device Publish Date | 2020-06-16 |
08809447652474 | INTELLIGENT TRACKING TIP_CLARITY II (INTELLIGENT TRACKING TIP, ROLLER_MAGNET, ROLLER_SUPPORT) |
08809447652467 | HANDPIECE ASSY_ST-A_CLARITY II_ICD (HANDPIECE_ST-A, FIBER, TIP_O_TYPE, TIP_SMALL_O_TYPE, TIP_STI |
08809447654027 | O Type IntelliTrak tip |
08809447652719 | CLARITY II ICD CAN ASSY 360g 1ea |
08809447652696 | GOGGLE 2ea |
08809447652689 | TIP_C_TYPE 5ea (Air type) |
08809447652672 | TIP_STICK_I_TYPE 2ea |
08809447652665 | TIP_SMALL_O_TYPE 2ea |
08809447652658 | TIP_O_TYPE 5ea (ICD type) |
08809447652610 | COMPL_BODY_AIR Package DI Number : 08809447652634 |
08809447652603 | HANDPIECE ASSY_ST-A_CLARITY II_AIR Package DI Number : 08809447652627 |
08809447652597 | CARTRIDGE_CLARITY II(2, 3_5, 8_10_12, 15_18_22, 16_20_24mm for USA) |
08809447652573 | CLARITY II Series Manual for USA(Operator's Manual) |
08809447652566 | FOOT SWITCH_CLARITY II(CLARITY II FOOT SWITCH) |
08809447652559 | COMPL_POLE_FIBER Package DI Number:08809447652627 |
08809447652634 | COMPL_BODY_ICD |
08809447652528 | HOLDER_WINDOW(Windoe holder) |
08809447652511 | FUSE |
08809447652504 | SPOT SIZE ALTERNATIVE PAPER |
08809447652498 | Tip WINDOW |