Foramatron® - Universal Reamer Holder for Foramatron® All Models - PARKELL, INC.

Duns Number:009900424

Device Description: Universal Reamer Holder for Foramatron® All Models

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


More Product Details

Catalog Number

D619RH

Brand Name

Foramatron®

Version/Model Number

D619RH

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2019

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

LQY

Product Code Name

Locator, Root Apex

Device Record Status

Public Device Record Key

8d428294-e4ab-45c5-be86-492c849751a9

Public Version Date

April 01, 2019

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKELL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 476
U Unclassified 19