Primary Device ID | 00817495020587 |
NIH Device Record Key | 4f926336-4595-464c-a03a-2b12dba1404c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Packaged 15-Pack of Cryogen (R134a / 980g / US) |
Version Model Number | 1600-00-0219 |
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 | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817495020587 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-05-06 |
Device Publish Date | 2024-04-26 |
00817495020587 - Packaged 15-Pack of Cryogen (R134a / 980g / US) | 2024-05-06Packaged 15-Pack of Cryogen (R134a / 980g / US) |
00817495020587 - Packaged 15-Pack of Cryogen (R134a / 980g / US) | 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / US) |
00817495023649 - Packaged 15-Pack of Cryogen (R134a / 980g / JP) | 2024-05-06 Packaged 15-Pack of Cryogen (R134a / 980g / JP) |
00817495024370 - Profound, SubQ Single- Use Cartridge, Packaged | 2024-03-08 Profound, SubQ Single- Use Cartridge, Packaged |
00817495024387 - Profound, Dermal Single- Use Cartridge, Packaged | 2024-03-08 Profound, Dermal Single- Use Cartridge, Packaged |
00817495023854 - GMPP Modified LSDS (HRDS) Options Kit for DCD | 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for DCD |
00817495023915 - GMPP Modified LSDS (HRDS) Options Kit for ACC | 2024-02-28 GMPP Modified LSDS (HRDS) Options Kit for ACC |
00817495025032 - HRDS Handpiece DCD Cooled | 2024-02-28 HRDS Handpiece DCD Cooled |
00817495025049 - HRDS Handpiece Air Cooled | 2024-02-28 HRDS Handpiece Air Cooled |