Richline Group, Inc. d/b/a Inverness

Basic Information

• Brand Name: Richline Group, Inc. d/b/a Inverness
• Primary DI: 00860014537103
• Version / Model: Version 0
• Catalog Number: 000IN2-20000WM
• Company Name: Richline Group, Inc.
• Labeler DUNS: 962801937
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-26
• Public Version: 1
• Public Version Date: 2026-03-06
• Public Version Status: New
• Public Device Record Key: b148c2e3-7bcb-4239-ac87-47d4e2c00cb4

Device Description

The Inverness 2000 Ear Piercing Earring provides a means for safe and reliable ear piercing. The product includes a reusable or single Ear Piercing instrument which holds an integrated disposable cartridge. The integrated cartridge houses both a piercing earring within a disposable protective capsule and a fully enclosed safety clutch. Hand pressure activation of the instrument advances the capsule from the cartridge to the ear lobe. Further hand pressure advances the piercing posted earring from the capsule, through the ear and into a fully enclosed safety clutch. The earring is released from the capsule as the earring decorative element passes through and breaks the capsule retention webs. The clutch is released as the post tip displaces the clutch and a clutch retention finger. A lidded cassette houses and protects the sterility of two cartridges and contents prior to use.

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: Yes
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JYS	Perforator, Ear-Lobe	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12991	Ear lobe perforator	An instrument used to pierce the lobe of the ear auricle (i.e., ear lobe) to create a hole in its tissue. It is typically designed as a device with a mechanism that forces a sharpened point (usually a starter earring) through the ear lobe by applying pressure to the handgrip. Although this device is primarily designed to piece the ear lobe, it can be used to pierce the ear cartilage and/or other parts of the body for, e.g., body piercing ornamentation purposes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860014537103	GS1