Enztec Reamer 63mm - Bridgeback 4250-9963

GUDID 09421038412992

A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure

ENZTEC LIMITED

Acetabular orthopaedic reamer

• Primary Device ID: 09421038412992
• NIH Device Record Key: 75b9d6ca-d993-4de7-968e-fede96430bcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enztec Reamer 63mm - Bridgeback
• Version Model Number: 4250-9963
• Catalog Number: 4250-9963
• 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	09421038412992 [Primary]

FDA Product Code

• HWE: Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Sterilization

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

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

[09421038412992]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-03
• Device Publish Date: 2026-02-23

Devices Manufactured by ENZTEC LIMITED

• 09421038412145 - Cup reamer handle, offset, Z/H, locking: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412152 - Offset coupling, Z/H: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412169 - Offset drive train, locking: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412176 - Short Offset Cover – United: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412183 - Handle – United: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412299 - Cup reamer handle, offset, AO, locking: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412305 - Offset coupling, AO: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure
• 09421038412312 - Cup reamer handle, offset, AO, open: 2026-03-17 A surgical instrument connected to an active device intended to be used during an orthopaedic surgical procedure