LITe TLIF - Specialty LITe TLIF Medial Blade Set - Stryker Corporation

Duns Number:149183167

Device Description: Specialty LITe TLIF Medial Blade Set

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More Product Details

Catalog Number

IS4566MIS

Brand Name

LITe TLIF

Version/Model Number

IS4566MIS

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)

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

3996c421-883a-407e-be7b-a446752c9308

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

July 07, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2688
2 A medical device with a moderate to high risk that requires special controls. 5304
3 A medical device with high risk that requires premarket approval 86