CALICO - Calcium Alginate Dressing 2" x 2" - Calico Medical Group LLC

Duns Number:118744421

Device Description: Calcium Alginate Dressing 2" x 2"

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More Product Details

Catalog Number

CAD001

Brand Name

CALICO

Version/Model Number

CAD001

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Device Record Status

Public Device Record Key

b5b5a6e4-5186-44aa-8b0f-123a77ae9e95

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Additional Identifiers

Package DI Number

20850044458343

Quantity per Package

40

Contains DI Package

00850044458349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"CALICO MEDICAL GROUP LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 4
U Unclassified 1