Exceed - The Exceed microneedling device is intended to - MT.DERM GmbH

Duns Number:329216357

Device Description: The Exceed microneedling device is intended to create many, very tiny, microscopic punctur The Exceed microneedling device is intended to create many, very tiny, microscopic puncturesin the epidermal and dermal layers of the skin using sterile stainless steel needles.Exceed consists of- Control Unit- Handpiece with handpiece cable- Handpiece Holder- Power Supply- Instructions for Use

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More Product Details

Catalog Number

AD61USMP

Brand Name

Exceed

Version/Model Number

AD61USMP

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

QAI

Product Code Name

Powered Microneedle Device

Device Record Status

Public Device Record Key

875fb118-fe95-4e7a-b3e5-61dc1defe9e3

Public Version Date

November 29, 2021

Public Version Number

4

DI Record Publish Date

October 23, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MT.DERM GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5