MedPride - Silver Calcium Alginate 2x2 - 10 pcs/bx - SHIELD-LINE, LLC

Duns Number:078518916

Device Description: Silver Calcium Alginate 2x2 - 10 pcs/bx

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More Product Details

Catalog Number

65272

Brand Name

MedPride

Version/Model Number

65272

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRO

Product Code Name

Dressing, Wound, Drug

Device Record Status

Public Device Record Key

707dd9ce-d0dd-434f-a130-b829d2a9952f

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

August 07, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SHIELD-LINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 1