FDA.reportPublic FDA data

Richline Group, Inc. d/b/a Inverness

Primary DI
00860013956516
Brand
Richline Group, Inc. d/b/a Inverness
Company
Richline Group, Inc.
Model
version 0
Device description
The Inverness 2000 Ear Piercing Earring provides a means for safe and reliable Nose piercing. The product includes a reusable or single Ear Piercing instrument which holds an integrated disposable cartridge. The integrated cartridge houses a stud within a disposable protective capsule. Hand pressure activation of the instrument advances the capsule from the cartridge to the Nose. Further hand pressure advances the piercing posted stud from the capsule through the Nose. The stud is released from the capsule as the stud is a decorative element passes through and breaks the capsule retention webs. A lidded cassette houses and protects the sterility of cartridge.
Published
2026-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
JYSPerforator, Ear-Lobe

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYSPerforator, Ear-LobeEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013956516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013956516008600139565168600139565160860013956516

GMDN Terms#

Term, Definition table
TermDefinition
Ear lobe perforatorAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
962801937
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013956509Richline Group, Inc. d/b/a InvernessVersion 0000IN2-C20000D2026-02-26
00860013956523Richline Greoup, Inc. d/b/a InvernessVersion 02026-02-26
00860013956561Richline Group, Inc. d/b/a InvernessVersion 02026-02-26
00860013956578Richline Group, Inc. d/b/a InvernessVersion 02026-02-26
00860013956585Richline Group, Inc. d/b/a Invernessversion 02026-02-26
00860013956592Richline Group, Inc. d/b/a InvernessVersion 02026-02-26
00860014537103Richline Group, Inc. d/b/a Inverness Version 0000IN2-20000WM2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462901906evonosevonos GmbH & Co. KGJYS2026-08-21
04054462907472evonosevonos GmbH & Co. KGJYS2026-08-21
04054462907489evonosevonos GmbH & Co. KGJYS2026-08-21
04054462907540evonosevonos GmbH & Co. KGJYS2026-08-21
04054462907557evonosevonos GmbH & Co. KGJYS2026-08-21
04054462907564evonosevonos GmbH & Co. KGJYS2026-08-21
04054462907571evonosevonos GmbH & Co. KGJYS2026-08-21
04054462901944evonosevonos GmbH & Co. KGJYS2026-08-18
00860013956509Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956523Richline Greoup, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956561Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956578Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956585Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860013956592Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00860014537103Richline Group, Inc. d/b/a InvernessRichline Group, Inc.JYS2026-02-26
00757770409228Bausch + LombBausch & Lomb IncorporatedJYS2025-08-15
04250676735539Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2023-08-30
04250381848449Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849491Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849507Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849514Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849538Fisch footplate perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-13
04250381849927Politzer tympanum perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-09
04250381849934Lucae tympanum perforatorSpiggle & Theis Medizintechnik GmbHJYS2022-09-09