Identity
- Trade Name
- AMO PHACO NEEDLE FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, single-use FDA UDI
- Device Name
- TIP TAPERED 45 DEGREE ROUND FDA UDI
- Model / Reference
- OPOR45T FDA UDI
- Description
- TIP TAPERED 45 DEGREE ROUND FDA UDI
Identifiers
- Catalog Number
- OPOR45T FDA UDI
- Primary DI / UDI-DI
- 05050474521209 FDA UDI
- FDA Product Code
- HQC FDA UDI
- GMDN Term
- Phacoemulsification system handpiece tip, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.4670 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Phacoemulsification system handpiece tip, single-use
Amo Phaco Needle by Johnson & Johnson Surgical Vision, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Phacoemulsification system handpiece tip, single-use.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Johnson & Johnson Surgical Vision, Inc.
Sources (1)
- FDA UDI 00f49698-8f81-442c-a010-f0c3a6e84916 35 fields · synced Jun 9, 2026