Up&Up - Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 - TARGET CORPORATION

Duns Number:006961700

Device Description: Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 IN (4.9 cm x 7.4 cm)

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More Product Details

Catalog Number

-

Brand Name

Up&Up

Version/Model Number

245070866

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

NAE

Product Code Name

Dressing, Wound, Hydrogel Without Drug And/Or Biologic

Device Record Status

Public Device Record Key

05ff1eb4-502e-4f76-bb6d-567e3bb369d9

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 27, 2020

Additional Identifiers

Package DI Number

10017276234890

Quantity per Package

72

Contains DI Package

00017276234893

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"TARGET CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 22
2 A medical device with a moderate to high risk that requires special controls. 52
U Unclassified 12