Catalog Number

-

Brand Name

Avalon Biomed NeoSEALER Flo 10 Flex Flo Tips (Int'l)

Version/Model Number

FFT10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 14, 2022

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EIC

Product Code Name

Syringe, Periodontic, Endodontic, Irrigating

Public Device Record Key

23323a04-b07c-499a-9bf3-ecde56745ec5

Public Version Date

September 15, 2022

Public Version Number

2

DI Record Publish Date

December 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-