CONDUIT LLIF Straight Trial Inserter LET20250T

GUDID 09421028117975

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

ENZTEC LIMITED

Orthopaedic implant inserter/extractor, reusable
Primary Device ID09421028117975
NIH Device Record Key22fa0802-d31c-4675-99db-cd59da7ea8af
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONDUIT LLIF Straight Trial Inserter
Version Model NumberLET20250T
Catalog NumberLET20250T
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
GS109421028117975 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


[09421028117975]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-09
Device Publish Date2023-05-01

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09421028113557 - Enztec Classic OCI - Trinket 5/16-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113571 - Enztec Classic OCI - Trinket 3/8-24 UNF-012026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410516 - ATTUNE FEMORAL IMPACTOR2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410523 - ATTUNE FEMORAL IMPACTOR HEAD2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

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