Bioplate® - BioMesh® Bender - Bioplate, Inc.

Duns Number:838734093

Device Description: BioMesh® Bender

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More Product Details

Catalog Number

AMB3-30

Brand Name

Bioplate®

Version/Model Number

AMB3-30

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

HAO

Product Code Name

Instrument, Surgical, Non-Powered

Device Record Status

Public Device Record Key

c020a6ae-e81c-4cd5-89d4-52b572291992

Public Version Date

February 23, 2022

Public Version Number

2

DI Record Publish Date

October 29, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOPLATE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 198
2 A medical device with a moderate to high risk that requires special controls. 506