Emerge Handpiece

GUDID 00841494100643

Emerge Handpiece Remanufactured

Cynosure, Inc.

Dermatological diode laser system
Primary Device ID00841494100643
NIH Device Record Keya0ff1e89-8ee7-47b2-8cc6-edabf9e91653
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmerge Handpiece
Version Model Number0520A-0001R
Company DUNS780318028
Company NameCynosure, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100841494100643 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONGPowered laser surgical instrument with microbeam\fractional output

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

On-Brand Devices [Emerge Handpiece]

00841494100643Emerge Handpiece Remanufactured
00841494100186Emerge Handpiece Assembly

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