Identity
- Trade Name
- FUSION DUAL PUMP PACK EUDAMEDWHITESTAR SIGNATURE FDA UDI
- Generic Name
- Surgical irrigation/aspiration tubing set FDA UDI
- Device Name
- PHACO TUBING PACK EUDAMEDOPO73 FUSION DUAL PUMP PACK FDA UDI
- Model / Reference
- OPO73 EUDAMEDFDA UDI
- Description
- OPO73 FUSION DUAL PUMP PACK FDA UDI
Identifiers
- Catalog Number
- OPO73 FDA UDI
- Primary DI / UDI-DI
- 15050474602080 EUDAMEDFDA UDI
- Basic UDI-DI
- 5050474a000159D EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Z1212020785 PHACO-VITRECTOMY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Surgical irrigation/aspiration tubing set FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Surgical irrigation/aspiration tubing set
Whitestar Signature by Johnson & Johnson Surgical Vision, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical irrigation/aspiration tubing set.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- ENDOFLOW II - PROBES - 4 holes diam.5 inch — Promepla · Class I
- Hysteroscopy set 2 spikes — Promepla · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
Sources (2)
- FDA UDI e8bd9022-5886-4fda-ba34-4ac862c614cd 35 fields · synced Oct 9, 2026
- EUDAMED 9942cc46-42ee-4d19-8f4d-216f01e0d431 61 fields · synced Oct 8, 2026