NA - IV Pole - STRYKER MEDTECH K.K.

Duns Number:690682147

Device Description: IV Pole

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More Product Details

Catalog Number

5450-850-028

Brand Name

NA

Version/Model Number

5450850028

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

-

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

-

Product Code Details

Product Code

FOX

Product Code Name

STAND, INFUSION

Device Record Status

Public Device Record Key

7ff9126c-e41c-48b6-bae5-b5e33c2e0dc1

Public Version Date

July 05, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER MEDTECH K.K." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 9
U Unclassified 8