Catalog Number

MI2550KE

Brand Name

DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT

Version/Model Number

1-hole

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K132353,K132353

Product Code

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Public Device Record Key

06b46842-0768-4c45-81fb-21089fe8f431

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 30, 2022

Package DI Number

03701068805497

Quantity per Package

20

Contains DI Package

03701068805480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX