Optiheal Ultra Thin Absorbent Film - Ultra Thin Absorbent Film 4x4in / 10x10cm - Neo G USA Inc

Duns Number:079218498

Device Description: Ultra Thin Absorbent Film 4x4in / 10x10cm

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More Product Details

Catalog Number

AW006

Brand Name

Optiheal Ultra Thin Absorbent Film

Version/Model Number

AW006

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

NAD

Product Code Name

Dressing, Wound, Occlusive

Device Record Status

Public Device Record Key

3f77072a-60f1-4a1e-b59e-b78e901c1fa8

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

January 19, 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