Armboard - Reison Medical AB

Duns Number:356766220

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More Product Details

Catalog Number

-

Brand Name

Armboard

Version/Model Number

10-388-US

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)

-

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

LGX

Product Code Name

Table, Examination, Medical, Powered

Device Record Status

Public Device Record Key

217cdc02-badb-4447-a40c-9128620f67e3

Public Version Date

May 09, 2022

Public Version Number

1

DI Record Publish Date

April 30, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REISON MEDICAL AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 261