Eclipse EVO Microneedling Cartridge 50EVO2000-010

GUDID 10853602008397

MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individually for single patient use.

ECLIPSE

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Primary Device ID10853602008397
NIH Device Record Key901ac6ee-621c-4faf-9505-09578b9e5180
Commercial Distribution StatusIn Commercial Distribution
Brand NameEclipse EVO Microneedling Cartridge
Version Model Number50EVO2000-010
Catalog Number50EVO2000-010
Company DUNS969752364
Company NameECLIPSE
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com
Phone800-759-6876
Emailinfo@eclipsemed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853602008390 [Primary]
GS110853602008397 [Package]
Contains: 00853602008390
Package: Case [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QAIPowered Microneedle Device

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-01-19
Device Publish Date2022-01-11

Devices Manufactured by ECLIPSE

10853602008397 - Eclipse EVO Microneedling Cartridge2022-01-19MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individually for single patient use.
10853602008397 - Eclipse EVO Microneedling Cartridge2022-01-19 MicroPen EVO Turbo Safety Cartridge (Each). Cartridges are sterilized and packaged individually for single patient use.
00853602008598 - Eclipse MicroPen EVO2022-01-19 Eclipse MicroPen EVO handpiece which is an automated, non-surgical microneedling device designed for use by licensed healthcare
00853602008604 - Eclipse Hypodermic Needle - 18G2022-01-19 Eclipse 18 Gauge Venting Needle - 18G x 1"; sterilized and individually packaged for single patient use. Venting needle is a com
00853602008611 - Eclipse Hypodermic Needle - 30G2022-01-19 Eclipse 30G Hypodermic Needle - 30G x 0.5"; sterilized and individually packaged for single patient use.
10853602008458 - Eclipse DermaFlex MicroCannula2021-03-31 DermaFlex Microcannula 22G/60mm + 21G/25mm
00853602008468 - Eclipse DermaFlex MicroCannula2021-03-31 DermaFlex Microcannula 22G/70mm + 21G/25mm Pilot
10853602008472 - Eclipse DermaFlex MicroCannula2021-03-31 DermaFlex Microcannula 25G/40mm + 23G/25mm Pilot
10853602008489 - Eclipse DermaFlex MicroCannula2021-03-31 DermaFlex Microcannula 25G/50mm + 23G/25mm Pilot
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