Avaline Medical NJ LLC - 200 Sterile 6" Cotton Tip Applicator - Avaline Medical NJ Limited Liability Company

Duns Number:079767953

Device Description: 200 Sterile 6" Cotton Tip Applicator

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More Product Details

Catalog Number

4305x1+st

Brand Name

Avaline Medical NJ LLC

Version/Model Number

4305x1+st

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

KXF

Product Code Name

APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Device Record Status

Public Device Record Key

cb175040-fc80-48a7-8902-e6d5bb8d0714

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 05, 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