TrellOss™-C SA - Straight Drill, Self Guided - NEXXT SPINE, LLC

Duns Number:003489810

Device Description: Straight Drill, Self Guided

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More Product Details

Catalog Number

-

Brand Name

TrellOss™-C SA

Version/Model Number

138N4040

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

ddf26257-13ae-4716-bbf2-7370aa8ece7c

Public Version Date

July 09, 2020

Public Version Number

1

DI Record Publish Date

July 01, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NEXXT SPINE, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1102
2 A medical device with a moderate to high risk that requires special controls. 4259
U Unclassified 91