Avaline Medical NJ LLC - Split Drain Sponge 4x4 6 Ply 100 plus Tape - Avaline Medical NJ Limited Liability Company

Duns Number:079767953

Device Description: Split Drain Sponge 4x4 6 Ply 100 plus Tape

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More Product Details

Catalog Number

4611 x2 +vt

Brand Name

Avaline Medical NJ LLC

Version/Model Number

4611 x2 +vt

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

48be8e5e-0479-4773-b2ba-57cca97cf9c3

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 03, 2021

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