BioPlug BioHorizons Sample - 20mm x 10mm - Collagen wound dressing - NOVABONE PRODUCTS, LLC

Duns Number:828813290

Device Description: Collagen wound dressing

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More Product Details

Catalog Number

BH2200-S

Brand Name

BioPlug BioHorizons Sample - 20mm x 10mm

Version/Model Number

BH2200-S

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)

Yes

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

2e59f64b-2abb-427a-9da7-76df98a1e6f1

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

September 14, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVABONE PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 80