CONDUIT ATP Inserter Hex Driver LET30401T

GUDID 09421028118354

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

ENZTEC LIMITED

Orthopaedic implant inserter/extractor, reusable
Primary Device ID09421028118354
NIH Device Record Key4d276280-f983-4ac8-b375-2fcf7d6b9db7
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONDUIT ATP Inserter Hex Driver
Version Model NumberLET30401T
Catalog NumberLET30401T
Company DUNS592616445
Company NameENZTEC LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109421028118354 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


[09421028118354]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-12
Device Publish Date2023-12-04

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09421038410639 - Patella Drill Guide – Restor3d Round 29-352025-06-02 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410646 - Patella Drill Guide – Restor3d Round 38-442025-06-02 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410554 - 3.5mm Ball Hex Driver – 225mm2025-04-21 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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