Optiheal Silicone Postsurgical Dressing - Silicone Postsurgical Dressing 8x4in / 20x10cm - Neo G USA Inc

Duns Number:079218498

Device Description: Silicone Postsurgical Dressing 8x4in / 20x10cm

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More Product Details

Catalog Number

AW002

Brand Name

Optiheal Silicone Postsurgical Dressing

Version/Model Number

AW002A

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)

-

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

9483960c-80cc-49f6-bd85-2dea5d9d5d78

Public Version Date

August 31, 2021

Public Version Number

1

DI Record Publish Date

August 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEO G USA INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14