MatrixPro sterilization case - PRO-DEX, INC.

Duns Number:849370358

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More Product Details

Catalog Number

-

Brand Name

MatrixPro sterilization case

Version/Model Number

60.000.010

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)

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

FRG

Product Code Name

Wrap, Sterilization

Device Record Status

Public Device Record Key

ca0b83c6-a5b0-43f3-ad50-211c61912988

Public Version Date

March 30, 2022

Public Version Number

5

DI Record Publish Date

March 27, 2020

Additional Identifiers

Package DI Number

10860540000208

Quantity per Package

10

Contains DI Package

00860540000201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PRO-DEX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 4