DEVICE: AMO PHACO NEEDLE (05050474521209)
Device Identifier (DI) Information
AMO PHACO NEEDLE
OPOR45T
In Commercial Distribution
OPOR45T
JOHNSON & JOHNSON SURGICAL VISION, INC.
OPOR45T
In Commercial Distribution
OPOR45T
JOHNSON & JOHNSON SURGICAL VISION, INC.
TIP TAPERED 45 DEGREE ROUND
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36215 | Phacoemulsification system handpiece tip, single-use |
A device that is attached to a dedicated handpiece for insertion into the eye to deliver energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). It may facilitate, via the handpiece, the irrigation/suction needed for the removal of debris. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HQC | Unit, phacofragmentation |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
00f49698-8f81-442c-a010-f0c3a6e84916
February 26, 2020
4
September 02, 2016
February 26, 2020
4
September 02, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
15050474521206 | 6 | 05050474521209 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(877)266-4543
JJV-US-SURGICALORDERS@ITS.JNJ.COM
JJV-US-SURGICALORDERS@ITS.JNJ.COM