MONDEAL

Basic Information

• Brand Name: MONDEAL
• Primary DI: 04050435040566
• Version / Model: 27-03904
• Catalog Number: 27-03904
• Company Name: MONDEAL Medical Systems GmbH
• Labeler DUNS: 312546955
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-26
• Public Version: 5
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: cf0d7010-7bb5-45e3-bd06-eed1f677eb3a
• Distribution End Date: 2018-12-31

Device Description

Washer Module 4 grey

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HTN	WASHER, BOLT NUT	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61670	Implantable bone washer	An implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04050435040566	GS1

Customer Contacts

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