CONDUIT ATP Cobb 18mm 36° Left 287361361

GUDID 09421028118422

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 ID09421028118422
NIH Device Record Key1692eb62-8934-46a6-9061-e28d62b0e059
Commercial Distribution StatusIn Commercial Distribution
Brand NameCONDUIT ATP Cobb 18mm 36° Left
Version Model Number287361361
Catalog Number287361361
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
GS109421028118422 [Primary]

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

Moist Heat or Steam Sterilization


[09421028118422]

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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09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119030 - Adjustable Cutting Block – 1.27mm2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119085 - MODULAR BROACH HANDLE, GRIP2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure

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