Primary Device ID | 00817495021843 |
NIH Device Record Key | 728fc933-aeab-41fa-91e3-52396e3d54c0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GentleLase 12/15/18MM RGD Delivery System W/DCD |
Version Model Number | 7122-00-3797 |
Company DUNS | 053468385 |
Company Name | CANDELA 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 | 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817495021843 [Primary] |
GS1 | 08174950201847 [Previous] |
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 | 5 |
Public Version Date | 2021-05-24 |
Device Publish Date | 2016-09-23 |
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