FDA.reportPublic FDA data

Safety Needle Cartridge 6-MNP 1.5 Exceed US

Primary DI
EMTDEMNPAED06USMP0
Brand
Safety Needle Cartridge 6-MNP 1.5 Exceed US
Company
MT.DERM GmbH
Model
EMNPAED06USMP
Catalog number
EMNPAED06USMP
Device description
The Safety Needle Cartridge is an accessory of Exceed AD61USMP.
Published
2018-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QAIPowered Microneedle Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QAIPowered Microneedle DeviceGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180778000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180778000Exceed Microneedling DeviceMt. Derm GmbH2018-09-07QAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EMTDEMNPAED06USMP1PackageHIBCC8In Commercial Distribution
EMTDEMNPAED06USMP0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic micro-needle cartridgeA sterile device intended to be fitted to an electronic cosmetic micro-needling handpiece for the creation of high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It is a small sealed cartridge containing micro-needles intended to be fitted to the distal tip of the handpiece; it does not include any injectable materials. It is intended to be used by a healthcare provider in a clinical setting. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Handling Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit
Storage Environment Humidity30 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature59 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329216357
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EMTDE104902USMP0FootswitchE104902USMP2026-06-08
EMTDEMNPA4806USMP0Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4806USMP2024-01-10
EMTDAD64901USMP0Bio Touch PrecisionAD64901USMP2026-05-22
EMTDCF104901USMP0Bio Touch AeroCF104901USMP2026-05-22
EMTDCG100206USMP0Exceed UnlimitedCG100206USMP2026-05-22
EMTDEMNPA4806USAMP06-MNP 1.5 ToskaniMED USAEMNPA4806USAMP2026-05-22
EMTDEMNPA4906USMP06-MNP 1.5 Exceed USEMNPA4906USMP2026-05-22
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0EMNPEX4906USMP2026-05-22
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0EMNPEY06USMP2026-05-22
EMTDAD61USMP0ExceedAD61USMPAD61USMP2018-10-23
EMTDAD61USMP1ExceedAD61USMPAD61USMP2018-10-23
EMTD104802USMP0Footswitch E104802USMP 2024-01-10
EMTDAD64801USMP1ExceedAD64801USMP2024-01-10
EMTDE100201USMP0Footswitch E100201USMP E100201USMP 2018-10-23
EMTDE100201USMP1Footswitch E100201USMP E100201USMP 2018-10-23
EMTDEMNPA4206USMP0Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4206USMP2020-01-01
EMTDAD64201USMP0ExceedAD64201USMP2020-01-01
EMTDE104201USMP0Footswitch E104201USMP 2020-01-01
EMTDEMNPA4206USMP1Safety Needle Cartridge 6-MNP 1.5 Exceed USEMNPA4206USMP2020-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EMTDE104902USMP0FootswitchMT.DERM GmbHQAI2026-06-08
EMTDAD64901USMP0Bio Touch PrecisionMT.DERM GmbHQAI2026-05-22
EMTDCF104901USMP0Bio Touch AeroMT.DERM GmbHQAI2026-05-22
EMTDCG100206USMP0Exceed UnlimitedMT.DERM GmbHQAI2026-05-22
EMTDEMNPA4806USAMP06-MNP 1.5 ToskaniMED USAMT.DERM GmbHQAI2026-05-22
EMTDEMNPA4906USMP06-MNP 1.5 Exceed USMT.DERM GmbHQAI2026-05-22
EMTDEMNPEX4906USMP06-MNP 1.5 Exceed II 2.0MT.DERM GmbHQAI2026-05-22
EMTDEMNPEY06USMP06-MNP 1.5 Exceed II 3.0MT.DERM GmbHQAI2026-05-22
08800016000443E-PENBOMTECH ELECTRONICS CO., LTD.QAI2026-04-29
00860015460646LuxPen Microneedling CartridgesT AESTHETICS LLCQAI2026-03-20
00860015460608LuxPenT AESTHETICS LLCQAI2026-03-12
00666151621244PRO Pen 14-Pin Microneedling CartridgeDermalogica, LLCQAI2026-01-31
00666151621305PRO Pen Microneedling SystemDermalogica, LLCQAI2026-01-31
B933ELKIT04ellacorCytrellis Biosystems, Inc.QAI2025-12-16
080555980600681NEED ProCAMPOMATS SRLQAI2025-12-03
080555980600751NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
080555980600511NEED ProCAMPOMATS SRLQAI2025-12-03
080555980600821NEED Pro Cartridges CAMPOMATS SRLQAI2025-12-03
B933ELSYS02R0ellacorCytrellis Biosystems, Inc.QAI2025-10-20
04260446131058XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131102XCELLARISPRO barrier sleeveDermaroller GmbHQAI2025-08-26
04260446131065XCELLARISPRO TWIST microneedling deviceDermaroller GmbHQAI2025-08-26
04260446131072XCELLARISPRO TWIST Control unitDermaroller GmbHQAI2025-08-26
04260446131089XCELLARISPRO TWIST HandpieceDermaroller GmbHQAI2025-08-26
04260446136268XCELLARISPRO Needling ModuleDermaroller GmbHQAI2025-08-26
B933EL03N029EllacorCytrellis Biosystems, Inc.QAI2025-06-12
00860012651016CytoPen NGEMAGE MEDICAL LLCQAI2025-05-22
00860012651030CytoPen S2EMAGE MEDICAL LLCQAI2025-05-22
00850061586018NanoPen Zizion Group Inc.QAI2024-12-26
B933ELCCV011EllacorCytrellis Biosystems, Inc.QAI2024-11-01