Performance Tool Organizer - Instrument holder intended to hold dental - ZIRC DENTAL PRODUCTS, INC.

Duns Number:064783913

Device Description: Instrument holder intended to hold dental instruments together through the sterilization p Instrument holder intended to hold dental instruments together through the sterilization process.

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More Product Details

Catalog Number

50Z940U

Brand Name

Performance Tool Organizer

Version/Model Number

U-Copper

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)

-

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

ccfb87a0-c113-45db-a41c-fb49d3e6e2b1

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIRC DENTAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 399