APmedical - (2 Qt/2 Lt SHARPS USA RED Disposable Square - ABM ITALIA SPA

Duns Number:338493631

Device Description: (2 Qt/2 Lt SHARPS USA RED Disposable Square Container w/White Lid) Single EA

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More Product Details

Catalog Number

-

Brand Name

APmedical

Version/Model Number

FGCS2NRS001 CS 2NR

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K071517

Product Code Details

Product Code

MMK

Product Code Name

Container, Sharps

Device Record Status

Public Device Record Key

c0824e97-b4b0-4509-a237-57b056018d7e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

August 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABM ITALIA SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 92