TIDI - CYLINDER 3.5 X 7 - TIDI PRODUCTS, LLC

Duns Number:063519193

Device Description: CYLINDER 3.5 X 7

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More Product Details

Catalog Number

33248

Brand Name

TIDI

Version/Model Number

33248

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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"

Yes

For Single-Use

-

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

KXJ

Product Code Name

Table, Radiologic

Device Record Status

Public Device Record Key

9634743c-14b6-4a17-b556-d513069134dd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 14, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TIDI PRODUCTS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 222
2 A medical device with a moderate to high risk that requires special controls. 2255