Richline Greoup, Inc. d/b/a Inverness
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Basic Information
- Brand Name
- Richline Greoup, Inc. d/b/a Inverness
- Primary DI
- 00860013956523
- Version / Model
- Version 0
- 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
- b3f9181e-ef87-4cec-a383-a364a80b37be
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
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 00860013956523 | GS1 |