Catalog Number

-

Brand Name

Alcedo

Version/Model Number

AE182

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K180984,K180984

Product Code

MMK

Product Code Name

Container, Sharps

Public Device Record Key

d8732757-534c-4e35-aab3-df71505928ce

Public Version Date

November 12, 2021

Public Version Number

1

DI Record Publish Date

November 04, 2021

Package DI Number

10856471007287

Quantity per Package

16

Contains DI Package

00856471007280

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton