MIXPAC Protective Sleeve - MIXPAC™ Protective Sleeves provide convenient and - Minitube AB

Duns Number:775295061

Device Description: MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-us MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protectthe dentist, staff and patient against cross-contamination and infectious disease during clinical use.

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More Product Details

Catalog Number

PRS 801-03

Brand Name

MIXPAC Protective Sleeve

Version/Model Number

50 ml

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K211026,K211026

Product Code Details

Product Code

PEM

Product Code Name

Dental Barriers And Sleeves

Device Record Status

Public Device Record Key

e7d3ddc1-9145-4c07-b255-979db0f77194

Public Version Date

October 11, 2022

Public Version Number

1

DI Record Publish Date

October 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MINITUBE AB" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3