SINPLUS S - TEKNIMED

Duns Number:764746723

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More Product Details

Catalog Number

8005

Brand Name

SINPLUS S

Version/Model Number

8005

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 15, 2019

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

NDN

Product Code Name

Cement, Bone, Vertebroplasty

Device Record Status

Public Device Record Key

083a3d90-5d1e-4581-b6b1-4237cf6215f9

Public Version Date

November 26, 2020

Public Version Number

4

DI Record Publish Date

October 16, 2015

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