Globe - Globe Non-Adherent Pads 3 x 8 Box of 50 - Trifecta Pharmaceuticals USA LLC

Duns Number:079424163

Device Description: Globe Non-Adherent Pads 3 x 8 Box of 50

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More Product Details

Catalog Number

-

Brand Name

Globe

Version/Model Number

20206

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Device Record Status

Public Device Record Key

903fcff9-a712-4998-a7ec-613f1a72aeb0

Public Version Date

March 08, 2021

Public Version Number

1

DI Record Publish Date

February 28, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TRIFECTA PHARMACEUTICALS USA LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5