NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982072429
• Version / Model: 03.111.500
• Catalog Number: 03111500
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-31
• Public Version: 4
• Public Version Date: 2023-09-01
• Public Version Status: Update
• Public Device Record Key: 08783012-3418-4c82-852d-87befc1c2626

Device Description

GUIDE BLOCK FOR TWO-COLUMN PLATE/NARROW 6H HD/RT

Device Characteristics

• Single Use: No
• 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: 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
FZX	Guide, surgical, instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61929	Orthopaedic implant aiming/guiding block attachment tool	A manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07611819394407	GS1
Secondary	H679031115000	HIBCC
Primary	10886982072429	GS1

Customer Contacts

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