NA

Basic Information

• Brand Name: NA
• Primary DI: 20886982182446
• Version / Model: 296.757
• Catalog Number: 296757
• Company Name: Synthes GmbH
• Labeler DUNS: 486711679
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2015-09-14
• Public Version: 4
• Public Version Date: 2022-05-02
• Public Version Status: Update
• Public Device Record Key: 9b71d25e-8fa6-40b8-a879-54c14df5108f

Device Description

6.0MM SACRAL NUTS/ROUNDED

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: 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
JDW	PIN, FIXATION, THREADED	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32847	Orthopaedic bone nut	A sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	H6792967570	HIBCC
Primary	20886982182446	GS1
Unit of Use	80886982182448	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K001720	000