Mixing Well - Mixing Well 144 pk - ZIRC DENTAL PRODUCTS, INC.

Duns Number:064783913

Device Description: Mixing Well 144 pk

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More Product Details

Catalog Number

-

Brand Name

Mixing Well

Version/Model Number

20Z496V

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"

-

For Single-Use

Yes

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

MDM

Product Code Name

Instrument, Manual, Surgical, General Use

Device Record Status

Public Device Record Key

12930f72-334e-4bcc-94a9-6d8d30d15311

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

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