Cool Cassette 2 Size 7 Instrument Tray Steel Gray - Instrument tray for dental tools - PRACTICON, INC.

Duns Number:119193803

Device Description: Instrument tray for dental tools

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More Product Details

Catalog Number

7141913 GRA

Brand Name

Cool Cassette 2 Size 7 Instrument Tray Steel Gray

Version/Model Number

7141914 GRA

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"

Yes

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

7ce582b5-e19d-4a15-986d-821658b0892e

Public Version Date

September 16, 2022

Public Version Number

5

DI Record Publish Date

December 04, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRACTICON, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 93
2 A medical device with a moderate to high risk that requires special controls. 2