FDA UDI
In Commercial Distribution
🇺🇸 United States
Rumex
DI: 00840159907689
·
Model: 16-030-16
·
RUMEX INTERNATIONAL CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rumex
- Primary DI
- 00840159907689
- Version / Model
- 16-030-16
- Catalog Number
- 16-030-16
- Company Name
- RUMEX INTERNATIONAL CORP.
- Labeler DUNS
- 041546137
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-22
- Public Version
- 1
- Public Version Date
- 2020-06-30
- Public Version Status
- New
- Public Device Record Key
- 71e63f68-1d77-4cf7-bcc7-1b88a05d8fa5
Device Description
Flieringa Rings, 16.00 mm, 1 each, Stainless Steel
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 |
|---|---|---|---|---|
| HNH | Ring, Ophthalmic (Flieringa) | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62917 | Eyeball fixation instrument, reusable | A hand-held, manual, ophthalmic surgical instrument intended to be used for fixation of the eyeball during a variety of ocular procedures. The distal end is configured as an open or closed ring with a fixed or swivelling attachment to a handle; the ring may be smooth or have blunt teeth. The instrument is typically metallic. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840159907689 | GS1 |