SCOUT® - MERIT MEDICAL SYSTEMS, INC.

Duns Number:117056277

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More Product Details

Catalog Number

SSR75-01/F

Brand Name

SCOUT®

Version/Model Number

00884450500576

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

NEU

Product Code Name

MARKER, RADIOGRAPHIC, IMPLANTABLE

Device Record Status

Public Device Record Key

2d0fa144-5f26-42f6-9850-8f2776787b91

Public Version Date

October 11, 2021

Public Version Number

2

DI Record Publish Date

May 12, 2021

Additional Identifiers

Package DI Number

10884450500573

Quantity per Package

5

Contains DI Package

00884450500576

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MERIT MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 32