Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Soft-tissue surgical hook, reusable FDA UDI
- Device Name
- Nagahara Phaco Chopper, Storz pattern, Flat Interior 60 Degree Cutting Edge for use in the RIGHT hand, Angled 10mm from bend to tip, Round Knurled Handle, 114mm Overall Length, Stainless Steel FDA UDI
- Model / Reference
- H1798R FDA UDI
- Description
- Nagahara Phaco Chopper, Storz pattern, Flat Interior 60 Degree Cutting Edge for use in the RIGHT hand, Angled 10mm from bend to tip, Round Knurled Handle, 114mm Overall Length, Stainless Steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412H1798R0 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 08a9a1c2-ee96-4f2d-ae36-8cba7a0c8e56 33 fields · synced May 29, 2026