Enztec Classic OCI - Trinket M8x0.75-01 4252-2087

GUDID 09421028117876

A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Orthopaedic implant impactor, reusable

Primary Device ID	09421028117876
NIH Device Record Key	2c69ed0b-ddb7-41c1-88b5-912ad366d034
Commercial Distribution Status	In Commercial Distribution
Brand Name	Enztec Classic OCI - Trinket M8x0.75-01
Version Model Number	4252-2087
Catalog Number	4252-2087
Company DUNS	592616445
Company Name	ENZTEC LIMITED
Device Count	1
DM Exempt	true
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421028117876 [Primary]

FDA Product Code

Impactor

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

[09421028117876]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-09-19
Device Publish Date	2023-09-11

Devices Manufactured by ENZTEC LIMITED

09421028110624 - Enztec Femoral Impactor - DJO	2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028110631 - DJO Femoral Impactor Head	2026-02-09 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
09421028112536 - Enztec Classic OCI - Trinket 5/16-24 UNF-02	2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113540 - Enztec Classic OCI - Trinket 3/8-16 UNC-01	2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113557 - Enztec Classic OCI - Trinket 5/16-24 UNF-01	2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421028113571 - Enztec Classic OCI - Trinket 3/8-24 UNF-01	2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410516 - ATTUNE FEMORAL IMPACTOR	2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
09421038410523 - ATTUNE FEMORAL IMPACTOR HEAD	2026-02-09 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure

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