PURE KIT - TEKNIMED

Duns Number:764746723

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More Product Details

Catalog Number

-

Brand Name

PURE KIT

Version/Model Number

T060425

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

JDZ

Product Code Name

Mixer, Cement, For Clinical Use

Device Record Status

Public Device Record Key

d386bd15-ee01-4290-8a15-8cfbc44c6c90

Public Version Date

May 11, 2022

Public Version Number

1

DI Record Publish Date

May 03, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TEKNIMED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25
2 A medical device with a moderate to high risk that requires special controls. 96