Catalog Number

AMC-25

Brand Name

Aseptico

Version/Model Number

AMC-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2032

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

-

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

5164ccca-342d-468d-9b51-c0560327b1fa

Public Version Date

July 20, 2022

Public Version Number

1

DI Record Publish Date

July 12, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-