Bioplate® - DEPTH GAUGE - Bioplate, Inc.

Duns Number:838734093

Device Description: DEPTH GAUGE

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

ADG5-01-SALE

Brand Name

Bioplate®

Version/Model Number

ADG5-01-SALE

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

fb86445f-5dfa-47c7-8bed-c89b2caa6ae2

Public Version Date

February 23, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2019

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