NL 100 Breast Marker

Basic Information

• Brand Name: NL 100 Breast Marker
• Primary DI: M996NL1000
• Version / Model: NL 100
• Catalog Number: NL 100
• Company Name: INSTRUMENTATION INDUSTRIES, INCORPORATED
• Labeler DUNS: 053146767
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-01
• Public Version: 1
• Public Version Date: 2019-10-09
• Public Version Status: New
• Public Device Record Key: 7bed0428-56d5-434b-b1aa-310e42af44b9

Device Description

NL 100 Breast Marker is used to assist in nipple placement during breast reconstructive surgery. A temporary impression is made by pressing the marker onto skin with a gentle rotating motion. Methylene blue may be used as a marking agent. The NL 100 Breast Marker provides two marking edges: 42 mm and 38 mm.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• PM Exempt: Yes
• 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: Ethylene Oxide, Radiation Sterilization, High-level Disinfectant

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64415	Skin marking guide, single-use	A device intended to be used as a guide to create an accurate mark on the skin surface with a drawing skin marker (e.g., a skin marking pen), or by itself after having been dipped in a marking agent (e.g., ink), typically to outline a surgical incision site or for dermatology applications. It is typically shaped specifically for its intended application. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M996NL1004	HIBCC	Ziplock bag	25	In Commercial Distribution
Primary	M996NL1000	HIBCC

Customer Contacts

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