Simpurity - Foam Dressing 4 x 5 inch with silicone (Each) - SAFE N' SIMPLE LLC

Duns Number:807812412

Device Description: Foam Dressing 4 x 5 inch with silicone (Each)

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More Product Details

Catalog Number

SNS74520

Brand Name

Simpurity

Version/Model Number

SNS74520

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)

Yes

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

3e2bbf07-3296-4a01-860f-309d84e5de3f

Public Version Date

December 08, 2021

Public Version Number

1

DI Record Publish Date

November 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAFE N' SIMPLE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 44
U Unclassified 15