ComfortMark

Basic Information

• Brand Name: ComfortMark
• Primary DI: B971CC151
• Version / Model: 1.5mm Lead Ball Conformable Nipple Marker (
• Company Name: Jessop Precision Products Inc.
• Labeler DUNS: 055127831
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 110
• Record Status: Published
• Publish Date: 2021-10-08
• Public Version: 1
• Public Version Date: 2021-10-18
• Public Version Status: New
• Public Device Record Key: a62cb6db-e6ef-4c00-9eac-c101733d96e2

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	892.1640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61577	Skin marking sticker	A hypoallergenic adhesive device (sticker) intended to be affixed to a patient’s skin (e.g., forehead) as a point of reference (marker), typically for use with external diagnostic imaging techniques. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	B971CC150	HIBCC
Primary	B971CC151	HIBCC

Customer Contacts

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