Equipment Stand - Universal Tray Kit - MAXTEC, LLC

Duns Number:169911828

Device Description: Universal Tray Kit

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More Product Details

Catalog Number

-

Brand Name

Equipment Stand

Version/Model Number

R100P86-001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

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

FOX

Product Code Name

Stand, Infusion

Device Record Status

Public Device Record Key

f4e59a3f-81ab-49c9-b496-8579e4d86b54

Public Version Date

February 14, 2019

Public Version Number

1

DI Record Publish Date

January 14, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXTEC, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 280
2 A medical device with a moderate to high risk that requires special controls. 235