Collo-MIS Double Offset Handle Right 9095.11.009

GUDID 09421028118323

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

ENZTEC LIMITED

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

• Primary Device ID: 09421028118323
• NIH Device Record Key: 865b23fd-2693-4e78-9a29-34783d8d8d48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collo-MIS Double Offset Handle Right
• Version Model Number: 9095.11.009
• Catalog Number: 9095.11.009
• Company DUNS: 592616445
• Company Name: ENZTEC LIMITED
• Device Count: 1
• DM Exempt: false
• 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	09421028118323 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

[09421028118323]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-03
• Device Publish Date: 2023-09-25

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• 09421028119016 - Double Offset Broach Handle M2 Connection - Left: 2024-02-16 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure