AETOS IM Sleeve CUT-0990-800-6

GUDID 09421038410592

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

ENZTEC LIMITED

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 09421038410592
• NIH Device Record Key: cf28d93a-a8d7-4a54-8449-4bcccd6fd98f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AETOS IM Sleeve
• Version Model Number: CUT-0990-800-6
• Catalog Number: CUT-0990-800-6
• 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	09421038410592 [Primary]

FDA Product Code

• FZX: Guide, Surgical, Instrument

Sterilization

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

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

[09421038410592]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-07
• Device Publish Date: 2025-07-30

Devices Manufactured by ENZTEC LIMITED

• 09421028119054 - Neck Holder: 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119061 - Base: 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119078 - Head Holder: 2025-10-06 A reusable manual surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119849 - Patella Drill Guide – Symbios XS-S-M: 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119856 - Patella Drill Guide – Symbios L - XL: 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119863 - Cement Clamp – Symbios XS-S: 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119870 - Cement Clamp – Symbios M-L-XL: 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure
• 09421028119887 - Cement Clamp Pad – Symbios XS-S: 2025-10-06 A reusable surgical instrument intended to be used during an orthopaedic surgical procedure