Standard Board - Octostop Inc

Duns Number:240536946

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More Product Details

Catalog Number

-

Brand Name

Standard Board

Version/Model Number

BO-02

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

KXH

Product Code Name

Cradle, patient, radiologic

Device Record Status

Public Device Record Key

d5b1ac77-7c1f-45a0-ab13-ed5fd1939e44

Public Version Date

May 23, 2019

Public Version Number

4

DI Record Publish Date

November 16, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OCTOSTOP INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 24