Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Soft-tissue surgical hook, reusable FDA UDI
- Device Name
- Nucleus Chopper Angled, Curved Interior Cutting Edge with .5mm Olive Shaped Tip, for use in the RIGHT HAND, Slightly Angled 15mm from bend to tip, Round Knurled Handle, 117mm Overall Length, Titanium FDA UDI
- Model / Reference
- PH6008LT FDA UDI
- Description
- Nucleus Chopper Angled, Curved Interior Cutting Edge with .5mm Olive Shaped Tip, for use in the RIGHT HAND, Slightly Angled 15mm from bend to tip, Round Knurled Handle, 117mm Overall Length, Titanium FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH6008LT0 FDA UDI
- FDA Product Code
- HNQ FDA UDI
- GMDN Term
- Soft-tissue surgical hook, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 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: Soft-tissue surgical hook, reusable
Mr Phaco by Crestpoint Management Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft-tissue surgical hook, reusable.
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class I
- MILLENNIUM — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- MSI Precision Specialty Instruments — Med Saver, Inc. · Class I
- V. Mueller — STERIS CORPORATION · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Crestpoint Management Ltd.
Sources (1)
- FDA UDI c501eeb4-956c-4e8d-a834-93e29fcbf65f 33 fields · synced May 30, 2026