PremierPro - AAMI 3 Gown, SMS, Tape Tab, Yellow, XL - SVS LLC

Duns Number:831375089

Device Description: AAMI 3 Gown, SMS, Tape Tab, Yellow, XL

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More Product Details

Catalog Number

-

Brand Name

PremierPro

Version/Model Number

2361

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)

Yes

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

FYC

Product Code Name

Gown, Isolation, Surgical

Device Record Status

Public Device Record Key

803c572d-2de4-4bef-818f-f20132ee6990

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 14, 2017

Additional Identifiers

Package DI Number

10818566010930

Quantity per Package

100

Contains DI Package

00818566010933

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