NA

Basic Information

• Brand Name: NA
• Primary DI: 10886982077677
• Version / Model: 03.306.000
• Catalog Number: 03306000
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 5
• Public Version Date: 2023-10-17
• Public Version Status: Update
• Public Device Record Key: 2d3a3e5a-d735-4355-b0fa-fe446467ef24

Device Description

INNER RAIL FOR PELVIC C-CLAMP II

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: No
• 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
JEC	COMPONENT, TRACTION, INVASIVE	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47873	Pelvic C-clamp	A manual surgical instrument designed as an emergency stabilization device for unstable injuries and fractures of the pelvic ring; these conditions can be associated with massive blood loss and terminal shock. It is mechanically fixed to either side of the pelvis by means of thick nails permitting quick and efficient compression and stabilization of pelvic fractures and luxations providing time for haemorrhage and embolization control. It is typically designed as a C-shaped frame with a rail, twin adjustable arms, adjusting side screws, and nails made of high-grade stainless steel and/or synthetic material. It is compatible for use in computed tomography (CT). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H679033060000	HIBCC
Primary	10886982077677	GS1
Direct Marking	07611819791374	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K071476	000