TigerView - TigerView Pro software version 7.7.13 - TELEVERE SYSTEMS, LLC

Duns Number:127132269

Device Description: TigerView Pro software version 7.7.13

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More Product Details

Catalog Number

TigerView Pro 7.7.13

Brand Name

TigerView

Version/Model Number

7.7.13

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K061035

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

6953a3fc-8601-472e-9653-5da112e3adae

Public Version Date

May 23, 2019

Public Version Number

6

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TELEVERE SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11