PREMIOtitan - PRIMOTEC LLC

Duns Number:153454736

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More Product Details

Catalog Number

-

Brand Name

PREMIOtitan

Version/Model Number

TI-10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

EJH

Product Code Name

Alloy, Metal, Base

Device Record Status

Public Device Record Key

cbe7d1a1-79e3-42f6-959b-57b5f7f2c23c

Public Version Date

September 07, 2020

Public Version Number

1

DI Record Publish Date

August 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRIMOTEC LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 177
U Unclassified 3