Avaline Medical NJ LLC - Gauze Sponge Pads - Non Sterile - 4 Ply - 3x3 - Avaline Medical NJ Limited Liability Company

Duns Number:079767953

Device Description: Gauze Sponge Pads - Non Sterile - 4 Ply - 3x3 x4000

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More Product Details

Catalog Number

20P NSG 3x3

Brand Name

Avaline Medical NJ LLC

Version/Model Number

20P NSG 3x3

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

NAB

Product Code Name

Gauze / sponge,nonresorbable for external use

Device Record Status

Public Device Record Key

fe348065-26d4-46f2-bc42-e6d3b8992203

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVALINE MEDICAL NJ LIMITED LIABILITY COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 263