Alphatec Spine Illico Illuminator - LUMITEX, INC.

Duns Number:108631797

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More Product Details

Catalog Number

73550

Brand Name

Alphatec Spine Illico Illuminator

Version/Model Number

006981

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"

Yes

For Single-Use

Yes

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

FDG

Product Code Name

Retractor, Fiberoptic

Device Record Status

Public Device Record Key

9a57e8a7-17b9-4621-896b-5e174ebdaa34

Public Version Date

October 06, 2020

Public Version Number

1

DI Record Publish Date

September 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LUMITEX, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 120
2 A medical device with a moderate to high risk that requires special controls. 4