FDA UDI
In Commercial Distribution
🇺🇸 United States
MSI Precision Specialty Instruments
DI: 00194613018375
·
Model: 9-25647-RR
·
Med Saver, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MSI Precision Specialty Instruments
- Primary DI
- 00194613018375
- Version / Model
- 9-25647-RR
- Company Name
- Med Saver, Inc.
- Labeler DUNS
- 556623486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-15
- Public Version
- 2
- Public Version Date
- 2025-07-30
- Public Version Status
- Update
- Public Device Record Key
- 00d6cc34-53b5-4c35-94fb-318acd0ccb10
Device Description
Seibel Style Nucleus Chopper / Safety Quick Chopper, Double Ended, Use In LH, RH Dominant Surgeon, Seibel End, Curved Interior Cutting Edge, 0.5mm Olive Shaped Tip, 15mm From Bend To Tip, Safety Chopper End, 0.5mm Olive Shaped Blade, 1mm Bend, Angled 10mm From Bend To Tip, Stainless Steel, Overall Length 5-1/2" (140mm)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HNQ | Hook, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13120 | Ophthalmic surgical probe, reusable | A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194613018375 | GS1 |
Customer Contacts
- Phone
- +1(610)935-8181
- [email protected]