Emerge Handpiece

GUDID 00841494100186

Emerge Handpiece Assembly

Cynosure, Inc.

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Primary Device ID	00841494100186
NIH Device Record Key	2238e355-bb34-43cc-8c06-7dd1d8b7cad4
Commercial Distribution Status	In Commercial Distribution
Brand Name	Emerge Handpiece
Version Model Number	0520A-0001
Company DUNS	780318028
Company Name	Cynosure, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841494100186 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K111840

FDA Product Code

ONG	Powered laser surgical instrument with microbeam\fractional output

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-09-24

On-Brand Devices [Emerge Handpiece]

00841494100643	Emerge Handpiece Remanufactured
00841494100186	Emerge Handpiece Assembly