HealiAid - HealiAid collagen wound dressing is fabricated by - MAXIGEN BIOTECH INC.

Duns Number:657266016

Device Description: HealiAid collagen wound dressing is fabricated by native fibrous, absorbable type I collag HealiAid collagen wound dressing is fabricated by native fibrous, absorbable type I collagen, purified from bovine Achilles tendons. HealiAid can greatly enchance and accelerate tissue ingrowth and support bone augmentation. SA304005 size: 30mm x 40mm x 5mm

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More Product Details

Catalog Number

SA304005

Brand Name

HealiAid

Version/Model Number

SA304005

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

KGN

Product Code Name

Dressing, Wound, Collagen

Device Record Status

Public Device Record Key

803c5e25-1468-42b7-a3b6-6b20cc94520d

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

July 23, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MAXIGEN BIOTECH INC." Characteristics
Device Class Device Class Description No of Devices
U Unclassified 3