MedEnvision Retractor 15 ME-EC0015

GUDID 09421028119825

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

ENZTEC LIMITED

Hand-held surgical retractor, reusable

• Primary Device ID: 09421028119825
• NIH Device Record Key: 51d88fda-1b11-4a91-bd3c-5d624c859c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MedEnvision Retractor 15
• Version Model Number: ME-EC0015
• Catalog Number: ME-EC0015
• 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	09421028119825 [Primary]

FDA Product Code

• GAD: Retractor

Sterilization

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

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

[09421028119825]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-11
• Device Publish Date: 2024-07-03

Devices Manufactured by ENZTEC LIMITED

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• 09421028118705 - MODULAR BROACH HANDLE, DUAL OFFSET, RIGHT: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118712 - MODULAR BROACH HANDLE, DUAL OFFSET, LEFT: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119030 - Adjustable Cutting Block – 1.27mm: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119085 - MODULAR BROACH HANDLE, GRIP: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119092 - MODULAR BROACH HANDLE, STRIKE PLATE: 2024-12-04 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure