FDA UDI
In Commercial Distribution
🇺🇸 United States
Rumex
DI: 00840159900215
·
Model: 16-141
·
RUMEX INTERNATIONAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rumex
- Primary DI
- 00840159900215
- Version / Model
- 16-141
- Catalog Number
- 16-141
- Company Name
- RUMEX INTERNATIONAL CORP.
- Labeler DUNS
- 041546137
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-09
- Public Version
- 1
- Public Version Date
- 2020-06-17
- Public Version Status
- New
- Public Device Record Key
- 8f58830b-a669-465e-a958-9a868085cbf3
Device Description
Alger Brush Rust Ring Remover With 0.50 mm Burr, Length 105 mm
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
- 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
- Yes
- Sterilization Methods
- ["Dry Heat Sterilization", "Ethylene Oxide", "Moist Heat or Steam Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HIY | Brush, Haidinger, (Including Macular Integrity) | Ophthalmic | 886.1090 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34880 | Eye brush | A brush intended to be used to gather tissue samples or to apply materials to the surface of the eye and/or its associated structures. This instrument typically consists of a handle at one end and bristles, fibres or spines, at the other. The bristles, fibres or spines may be mounted along a single plane or radiate out around a central shaft. The shaft-like handle may be flexible or rigid and the bristles may be soft or stiff. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840159900215 | GS1 |