BOWL AND SPATULA - Bowl and Spatula are accessories intended for - TECRES SPA

Duns Number:435428396

Device Description: Bowl and Spatula are accessories intended for bone cement mixing.

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More Product Details

Catalog Number

-

Brand Name

BOWL AND SPATULA

Version/Model Number

CPSP-02

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)

-

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

JDZ

Product Code Name

Mixer, Cement, For Clinical Use

Device Record Status

Public Device Record Key

e2c17e7b-9812-4c70-81be-f3e6e9465deb

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 23, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECRES SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 52