Gel-Care Advanced Body Wrap, 3" x 36" - Silipos Holding LLC

Duns Number:056112948

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More Product Details

Catalog Number

-

Brand Name

Gel-Care Advanced Body Wrap, 3" x 36"

Version/Model Number

620

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

-

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

ed0801d7-9c4a-40aa-a76a-d97594a0eda5

Public Version Date

August 15, 2022

Public Version Number

1

DI Record Publish Date

August 05, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SILIPOS HOLDING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 602