PremierPro - Disposable Transfer Mat, REMUV, 36" - SVS LLC

Duns Number:831375089

Device Description: Disposable Transfer Mat, REMUV, 36"

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More Product Details

Catalog Number

3770

Brand Name

PremierPro

Version/Model Number

3770

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"

Yes

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

FMR

Product Code Name

Device, Transfer, Patient, Manual

Device Record Status

Public Device Record Key

9afaeb7e-1225-42b7-af41-c29e17cd5712

Public Version Date

September 03, 2020

Public Version Number

1

DI Record Publish Date

August 26, 2020

Additional Identifiers

Package DI Number

10811220032354

Quantity per Package

10

Contains DI Package

00811220032357

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"SVS LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 486
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 1