Midmark

Basic Information

• Brand Name: Midmark
• Primary DI: 00841709116643
• Version / Model: 9A512001-870
• Catalog Number: 9A512001-870
• Company Name: MIDMARK CORPORATION
• Labeler DUNS: 005036025
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-07
• Public Version: 3
• Public Version Date: 2023-02-03
• Public Version Status: Update
• Public Device Record Key: e2a78545-cfe8-47e3-9f51-65e7a50a8ff4

Device Description

The Midmark 630 U-Shaped UltraFree Headrest, Latte colored, is designed to provide proper, yet comfortable, support of the head and neck for patients in the prone position. The positioning flexibility helps ensure proper alignment of the patient's back for increased comfort during exams or procedures.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GBB	CHAIR, SURGICAL, AC-POWERED	General, Plastic Surgery	878.4960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58055	Operating/examination/treatment table headrest, reusable	A device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest available in various shapes and sizes and might include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00841709116643	GS1

Customer Contacts

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