CONDUIT LLIF Squid Inserter - Intended to be used for the insertion of spinal - ENZTEC LIMITED

Duns Number:592616445

Device Description: Intended to be used for the insertion of spinal implants into the spinal space during tota Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.

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More Product Details

Catalog Number

LET30290T

Brand Name

CONDUIT LLIF Squid Inserter

Version/Model Number

LET30290T

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

-

Product Code Details

Product Code

MAX

Product Code Name

Intervertebral Fusion Device With Bone Graft, Lumbar

Device Record Status

Public Device Record Key

efd044d6-a661-4dd8-bfaf-2d119587ff50

Public Version Date

July 11, 2022

Public Version Number

1

DI Record Publish Date

July 01, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENZTEC LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 107
2 A medical device with a moderate to high risk that requires special controls. 7