Primary Device ID | 08800035500481 |
NIH Device Record Key | 5c5fe79f-c67f-48d0-8abb-2c5b8f4d26da |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HYPERION Foot Switch |
Version Model Number | HYPERION Foot Switch |
Company DUNS | 689856875 |
Company Name | Laseroptek Co.,Ltd |
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 | 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 |
Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08800035500481 [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 | 4 |
Public Version Date | 2020-02-06 |
Device Publish Date | 2018-01-12 |
08800035501839 - PALLAS Premium Body | 2023-02-16 PALLAS Premium Body |
08800035501778 - PALLAS Premium Arm | 2023-02-16 PALLAS Premium Arm |
08800035501785 - PALLAS Premium Handpiece - 12 x 12 | 2023-02-16 PALLAS Premium Handpiece - 12 x 12 |
08800035501792 - PALLAS Premium Handpiece - 15 x 15 | 2023-02-16 PALLAS Premium Handpiece - 15 x 15 |
08800035501808 - PALLAS Premium Handpiece - 18 x 18 | 2023-02-16 PALLAS Premium Handpiece - 18 x 18 |
08800035501815 - PALLAS Premium Foot Switch | 2023-02-16 PALLAS Premium Foot Switch |
08800035501822 - PALLAS Premium User Manual | 2023-02-16 PALLAS Premium User Manual |
08800035501730 - HELIOS 785 Pico Body | 2023-01-13 HELIOS 785 Pico Body |