FDA UDI
In Commercial Distribution
🇺🇸 United States
MSI Precision Specialty Instruments
DI: 00194613086435
·
Model: 581049
·
Med Saver, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MSI Precision Specialty Instruments
- Primary DI
- 00194613086435
- Version / Model
- 581049
- Company Name
- Med Saver, Inc.
- Labeler DUNS
- 556623486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-01
- Public Version
- 1
- Public Version Date
- 2025-08-11
- Public Version Status
- New
- Public Device Record Key
- 6ad16ca1-e077-410a-a262-d168a58a67a3
Device Description
Surgical Glide (Fichman), 30mm Long; 6mm Thick; Phaco Glide 10mm Long x 2.6mm Wide, Tapered To 1.75mm, IOL Glide Portion; 20mm Long x 5mm Wide, 2.5mm Radius, Box Of 50
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KYB | LENS, GUIDE, INTRAOCULAR | Ophthalmic | 886.4300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47725 | Manual intraocular lens injector, single-use | A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194613086435 | GS1 |
Customer Contacts
- Phone
- +1(610)935-8181
- [email protected]