Catalog Number

107

Brand Name

T-SPeC

Version/Model Number

T7

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K120127,K120127

Product Code

FEX

Product Code Name

Instrument, Catheter, Punch

Public Device Record Key

6252f336-944a-469f-b8aa-3535d500e4c5

Public Version Date

April 01, 2020

Public Version Number

3

DI Record Publish Date

March 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-