PremierPro - PremierPro Disposable Scrub Pant, Elastic Waist, - SVS LLC

Duns Number:831375089

Device Description: PremierPro Disposable Scrub Pant, Elastic Waist, Blue, Medium, 10/bg

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More Product Details

Catalog Number

2843P

Brand Name

PremierPro

Version/Model Number

2843P

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Device Record Status

Public Device Record Key

ca8182e5-fe3f-46fa-9576-41d8ce70f702

Public Version Date

August 07, 2020

Public Version Number

1

DI Record Publish Date

July 30, 2020

Additional Identifiers

Package DI Number

10818566011807

Quantity per Package

6

Contains DI Package

00818566011800

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