Identity
- Trade Name
- LAMINAR FDA UDI
- Generic Name
- Phacoemulsification system handpiece tip, reusable FDA UDI
- Device Name
- LMNR FLOW PHACO CVD TIP 45D 21G SL REUSE FDA UDI
- Model / Reference
- OPOCR4521R EUDAMEDFDA UDI
- Description
- LMNR FLOW PHACO CVD TIP 45D 21G SL REUSE FDA UDI
Identifiers
- Catalog Number
- OPOCR4521R FDA UDI
- Primary DI / UDI-DI
- D-USMF0000389680020836L EUDAMED05050474573314 FDA UDI
- Basic UDI-DI
- B-USMF0000389680020836L EUDAMED
- FDA Product Code
- HQC FDA UDI
- EMDN Code
- Q020699 PHACOEMULSIFICATION DEVICES - OTHER EUDAMED
- GMDN Term
- Phacoemulsification system handpiece tip, reusable 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
No
Implantable
No
Reusable
Yes
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: Phacoemulsification system handpiece tip, reusable
Laminar by Johnson & Johnson Surgical Vision, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Phacoemulsification system handpiece tip, reusable.
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- MST/Packard .7mm Straight Phaco Tip 15° — MICROSURGICAL TECHNOLOGY, INC. · Class II
- MST/Packard A1 .7mm 12º Bend Phaco Tip, Reverse Bevel — MICROSURGICAL TECHNOLOGY, INC. · Class II
- MST/Packard A1 .7mm 12° Bend Phaco Tip Dewey, Reverse Bevel — MICROSURGICAL TECHNOLOGY, INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | 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 63804a14-ea57-4e46-9b38-ebcf7fac681a 35 fields · synced Aug 1, 2026
- EUDAMED 009b0e89-459c-493e-929a-eca9236c6ccd 61 fields · synced Aug 1, 2026