Primary Device ID | 00647529004159 |
NIH Device Record Key | e4f3a277-1c16-4927-a0b8-affe4014781b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Epic Hygiene Diode Laser System |
Version Model Number | Handpiece, 1pk |
Catalog Number | 7420006 |
Company DUNS | 152165700 |
Company Name | Biolase, Inc. |
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 |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com | |
Phone | 1-800-321-6717 |
Diodeservice@biolase.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00647529004159 [Primary] |
GEX | Powered Laser Surgical Instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
[00647529004159]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-06-27 |
Device Publish Date | 2023-06-19 |
00647529003817 | A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The system i |
00647529004166 | A dental 980nm diode laser system intended for a variety of soft-tissue procedures. The system i |
00647529004159 | A handpiece for a dental 980nm diode laser system intended for a variety of soft-tissue procedur |