RadBoard®Xtra™ - Merit Medical Systems, Inc.

Duns Number:184763290

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More Product Details

Catalog Number

RBX/B

Brand Name

RadBoard®Xtra™

Version/Model Number

00884450203200

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

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

BWN

Product Code Name

TABLE AND ATTACHMENTS, OPERATING-ROOM

Device Record Status

Public Device Record Key

83aca0c6-f6a2-4031-9bc7-1bdeccaa29f2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 16, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERIT MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 573
2 A medical device with a moderate to high risk that requires special controls. 8779