FDA UDI
In Commercial Distribution
🇺🇸 United States
MR PHACO
DI: G412PH92370
·
Model: PH9237
·
Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MR PHACO
- Primary DI
- G412PH92370
- Version / Model
- PH9237
- Company Name
- Crestpoint Management Limited
- Labeler DUNS
- 836285668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-07
- Public Version
- 1
- Public Version Date
- 2025-06-16
- Public Version Status
- New
- Public Device Record Key
- 0df8aa0e-3e0f-42f9-9986-5e29a4aec870
Device Description
Murdoch Adjustable Slide Speculum with Lock control screw, 15mm Closed Square Blades, 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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HNC | Specula, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35010 | Lacrimal dilator, reusable | A hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G412PH92370 | HIBCC |