FDA UDI
In Commercial Distribution
🇺🇸 United States
MSI Precision Specialty Instruments
DI: 00194613121808
·
Model: OHSOG-LH
·
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
- 00194613121808
- Version / Model
- OHSOG-LH
- Company Name
- Med Saver, Inc.
- Labeler DUNS
- 556623486
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-21
- Public Version
- 2
- Public Version Date
- 2025-07-30
- Public Version Status
- Update
- Public Device Record Key
- 9c11a7da-a68f-4495-951a-b825c8fd39ea
Device Description
Hill Open Access Surgical Gonio Lens, Held in Left Hand, Increased Clearance To Clear Cornea, Surface Area 54mm, Gonio Magnification 1.2x, Field of View 90 Degrees, Handle Length 78mm
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 |
|---|---|---|---|---|
| HKS | Prism, gonioscopic | Ophthalmic | 886.1660 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11894 | Gonioscope | A device intended to be used to examine the angle of the anterior chamber of the eye and for demonstrating ocular motility and rotation. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00194613121808 | GS1 |
Customer Contacts
- Phone
- +1(610)935-8181
- [email protected]