PremierPro - PremierPro Foam Economy Wrap Back with 1 hot/cold - SVS LLC

Duns Number:831375089

Device Description: PremierPro Foam Economy Wrap Back with 1 hot/cold pack

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More Product Details

Catalog Number

1215PP

Brand Name

PremierPro

Version/Model Number

1215PP

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)

Yes

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

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Device Record Status

Public Device Record Key

7198cc0e-9852-4e8f-b512-fc37f42efa15

Public Version Date

September 14, 2020

Public Version Number

1

DI Record Publish Date

September 04, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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