Safety Needle Cartridge 6-MNP 1.5 Exceed US

GUDID EMTDEMNPA4206USMP1

The Safety Needle Cartridge is an accessory of Exceed.

MT.DERM GmbH

Cosmetic micro-needle cartridge
Primary Device IDEMTDEMNPA4206USMP1
NIH Device Record Keye6e6dd36-94d1-4643-b035-fc4541fd86d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSafety Needle Cartridge 6-MNP 1.5 Exceed US
Version Model NumberEMNPA4206USMP
Company DUNS329216357
Company NameMT.DERM GmbH
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Handling Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Storage Environment HumidityBetween 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEMTDEMNPA4206USMP0 [Primary]
HIBCCEMTDEMNPA4206USMP1 [Package]
Contains: EMTDEMNPA4206USMP0
Package: Box [8 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 Date2020-01-09
Device Publish Date2020-01-01

On-Brand Devices [Safety Needle Cartridge 6-MNP 1.5 Exceed US]

EMTDEMNPAED06USMP0The Safety Needle Cartridge is an accessory of Exceed AD61USMP.
EMTDEMNPA4206USMP1The Safety Needle Cartridge is an accessory of Exceed.

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