Offset Acetabular Shell Impactor Hex Driver - Enztec

Basic Information

• Brand Name: Offset Acetabular Shell Impactor Hex Driver - Enztec
• Primary DI: 09421038411612
• Version / Model: 1080-0-1501
• Catalog Number: 1080-0-1501
• Company Name: ENZTEC LIMITED
• Labeler DUNS: 592616445
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 2
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: 3aeca5c2-45e4-4f55-895c-d93df7f39211

Device Description

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

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWA	Impactor	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32856	Orthopaedic implant impactor, reusable	A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	09421038411612	GS1