Bone Hook ME-BH0001

GUDID 09421028119108

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

ENZTEC LIMITED

Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook Bone hook

• Primary Device ID: 09421028119108
• NIH Device Record Key: e4ee4eab-3473-45ca-9dfe-413ccd43d6cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bone Hook
• Version Model Number: ME-BH0001
• Catalog Number: ME-BH0001
• 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	09421028119108 [Primary]

FDA Product Code

• KIK: Hook, Bone

Sterilization

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

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

[09421028119108]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-19
• Device Publish Date: 2024-03-11

Devices Manufactured by ENZTEC LIMITED

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• 09421028119245 - Enztec Trinket M10X1.00-01: 2024-03-21 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119108 - Bone Hook: 2024-03-19A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119108 - Bone Hook: 2024-03-19 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118910 - PROCOTYL® P ENZTEC LINER IMPACTOR ADAPTER: 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028118941 - PROCOTYL® P ENZTEC STRAIGHT HANDLE: 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119023 - Enztec Straight Cup Impactor: 2024-03-08 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119009 - Double Offset Broach Handle M2 Connection - Right: 2024-02-16 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 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