Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Corneal marker, reusable FDA UDI
- Device Name
- Intra-Op Toric Axis Marker II with two 2mm marking blades, Relief cuts on the two 180 degree positions to allow for easy alignment, 125mm Overall Length, Round Knurled Handle mounted in the 90 degree position, Titanium FDA UDI
- Model / Reference
- PH9515T FDA UDI
- Description
- Intra-Op Toric Axis Marker II with two 2mm marking blades, Relief cuts on the two 180 degree positions to allow for easy alignment, 125mm Overall Length, Round Knurled Handle mounted in the 90 degree position, Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH9515T0 FDA UDI
- FDA Product Code
- HMR FDA UDI
- GMDN Term
- Corneal marker, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Corneal marker, reusable
Mr Phaco by Crestpoint Management Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Crestpoint Management Ltd.
Sources (1)
- FDA UDI 0f12c668-f74e-4d3c-a7ce-d7252c181ab6 33 fields · synced May 30, 2026