Identity
- Trade Name
- MR PHACO FDA UDI
- Generic Name
- Soft-tissue surgical hook, reusable FDA UDI
- Device Name
- Gulani Harpoon Universal Chopper/Manipulator, Harpoon end 60° curved, tip 0.75mm x 0.51mm x 2.0mm, Chopper end 45° angled shaft, 90° angled tip, Round Knurled Handle, 115mm Overall Length, Stainless steel FDA UDI
- Model / Reference
- PH6013 FDA UDI
- Description
- Gulani Harpoon Universal Chopper/Manipulator, Harpoon end 60° curved, tip 0.75mm x 0.51mm x 2.0mm, Chopper end 45° angled shaft, 90° angled tip, Round Knurled Handle, 115mm Overall Length, Stainless steel FDA UDI
Identifiers
- Primary DI / UDI-DI
- G412PH60130 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 13149396-fe69-48a5-94e1-f68e542c7f0f 33 fields · synced May 31, 2026