CVS Health™ - Waterproof Hydrogel Burn Pads Instant Cooling - WOONSOCKET PRESCRIPTION CENTER, INCORPORATED

Duns Number:062312574

Device Description: Waterproof Hydrogel Burn Pads Instant Cooling Relief

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More Product Details

Catalog Number

334886

Brand Name

CVS Health™

Version/Model Number

334886

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)

Yes

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

6522b9a0-205a-47c3-b6f5-512244db0750

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"WOONSOCKET PRESCRIPTION CENTER, INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 139
U Unclassified 23