SAVI® - MERIT MEDICAL SYSTEMS, INC.

Duns Number:117056277

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More Product Details

Catalog Number

SAVI-10GAMMA/B

Brand Name

SAVI®

Version/Model Number

00884450434437

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

JAQ

Product Code Name

System, applicator, radionuclide, remote-controlled

Device Record Status

Public Device Record Key

f131456c-7640-4fa9-b1c2-c8ce0d3a7fbe

Public Version Date

March 08, 2022

Public Version Number

1

DI Record Publish Date

February 28, 2022

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
2 A medical device with a moderate to high risk that requires special controls. 32