A Plus - Mayo stand cover - A PLUS INTERNATIONAL INC.

Duns Number:191705904

Device Description: Mayo stand cover

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More Product Details

Catalog Number

MS-2354-1

Brand Name

A Plus

Version/Model Number

1

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"

Yes

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 Details

Product Code

KKX

Product Code Name

Drape, Surgical

Device Record Status

Public Device Record Key

18a0a569-f8b0-4589-86a7-fbaf6e615fa5

Public Version Date

August 11, 2020

Public Version Number

1

DI Record Publish Date

August 03, 2020

Additional Identifiers

Package DI Number

80683534210235

Quantity per Package

2640

Contains DI Package

00683534210239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"A PLUS INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 83
2 A medical device with a moderate to high risk that requires special controls. 23
U Unclassified 29