FDA UDI
In Commercial Distribution
🇺🇸 United States
MR PHACO
DI: G412PH9408T0
·
Model: PH9408T
·
Crestpoint Management Limited
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MR PHACO
- Primary DI
- G412PH9408T0
- Version / Model
- PH9408T
- Company Name
- Crestpoint Management Limited
- Labeler DUNS
- 836285668
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-09
- Public Version
- 1
- Public Version Date
- 2025-06-17
- Public Version Status
- New
- Public Device Record Key
- bc941ee8-3e70-4b7e-acc6-73ec976d900d
Device Description
Nichamin Degree Gauge with open front, 12mm ID with 10 Degree markings on top of ring for easy alignment, 102mm Overall Length, Diamond knurled handle, 112mm total length, Titanium
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 |
|---|---|---|---|---|
| HOE | Caliper, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44796 | Medical ruler, reusable | A small straight-edged strip intended to be used to measure the length of internal or external anatomy, devices or instruments in a clinical setting. It is marked in units of length (i.e., inches, millimetres and/or centimetres), and may be an independent rigid or bendable strip applied to measured surfaces or a strip incorporated into a form convenient for measuring specific devices (e.g., screws, endodontic files/rasps). It is not an implant sizer/prosthesis trial of a predetermined size, nor is it dedicated to wound measurements. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G412PH9408T0 | HIBCC |