Catalog Number

AMC-15-220

Brand Name

Aseptico

Version/Model Number

AMC-15-220

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 31, 2030

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

-

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

K101332

Product Code

EIA

Product Code Name

Unit, Operative Dental

Public Device Record Key

73570a6d-f545-486a-a77b-4bc8e89dcf31

Public Version Date

August 12, 2020

Public Version Number

1

DI Record Publish Date

August 04, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-