Cardinal Thumb Transparent Dressing - The dressings are intended for wound care - ASPEN SURGICAL PRODUCTS, INC.

Duns Number:027680821

Device Description: The dressings are intended for wound care applications and securing objects to the skin.

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More Product Details

Catalog Number

-

Brand Name

Cardinal Thumb Transparent Dressing

Version/Model Number

TD-22CNS

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

NAD

Product Code Name

Dressing, wound, occlusive

Device Record Status

Public Device Record Key

fbde6fb8-d7c4-4ade-a693-5dea9f5200e3

Public Version Date

June 15, 2022

Public Version Number

2

DI Record Publish Date

February 25, 2021

Additional Identifiers

Package DI Number

00840113205622

Quantity per Package

1600

Contains DI Package

00840113205615

Package Discontinue Date

February 25, 2021

Package Status

Not in Commercial Distribution

Package Type

-

"ASPEN SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 952
2 A medical device with a moderate to high risk that requires special controls. 494