TiWAVE L Lumbar Cage System - Trial, 28 x 8mm, 0 Degree,No Taper, Straight - Kalitec Direct LLC

Duns Number:041956211

Device Description: Trial, 28 x 8mm, 0 Degree,No Taper, Straight

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More Product Details

Catalog Number

-

Brand Name

TiWAVE L Lumbar Cage System

Version/Model Number

23-LTN-2808

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)

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

HWT

Product Code Name

Template

Device Record Status

Public Device Record Key

73dc710a-6894-4f61-85db-cab14405b9f6

Public Version Date

March 01, 2019

Public Version Number

1

DI Record Publish Date

January 29, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KALITEC DIRECT LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1286
2 A medical device with a moderate to high risk that requires special controls. 1900