DISPOSABLE MICRO CANNULA FOR FILLER INJECTION - Flexible micro cannulas to inject a filler - AESTHETIC GROUP

Duns Number:260069352

Device Description: Flexible micro cannulas to inject a filler (synthetic or autologous fat) under the skin.

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More Product Details

Catalog Number

MI2450KR

Brand Name

DISPOSABLE MICRO CANNULA FOR FILLER INJECTION

Version/Model Number

24gauge x 5 cm - 1-hole

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Device Record Status

Public Device Record Key

9ec38668-51df-4a10-89ee-c1978be90d00

Public Version Date

December 12, 2019

Public Version Number

3

DI Record Publish Date

August 16, 2018

Additional Identifiers

Package DI Number

03760037735050

Quantity per Package

20

Contains DI Package

03760037735067

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"AESTHETIC GROUP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 92
2 A medical device with a moderate to high risk that requires special controls. 49