OPERACE

Basic Information

• Brand Name: OPERACE
• Primary DI: 07610733852963
• Version / Model: 80296
• Catalog Number: 80296
• Company Name: PB SWISS TOOLS AG
• Labeler DUNS: 487856262
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-09-24
• Public Version: 1
• Public Version Date: 2024-10-02
• Public Version Status: New
• Public Device Record Key: 9940e71a-9bac-4078-9f00-1c8478ac13f3

Device Description

Sterile singel-use trials. Identify the size of the sterile screwdriver insert

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HXB	Probe	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64122	Surgical screwdriver trial	A hand-held tool intended to be used to determine the correct size of surgical screwdriver or screwdriver insert required to insert or remove an implantable bone screw. It consists of a set of polymer rods with distal ends in graduated sizes to fit into one of the variations of screw head (e.g., Hex, square, cross-head). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07610733852963	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]