DEVICE: CLARIFLEX (05050474514577)
Device Identifier (DI) Information
CLARIFLEX
CLRFLXC
In Commercial Distribution
CLRFLXC295
JOHNSON & JOHNSON SURGICAL VISION, INC.
CLRFLXC
In Commercial Distribution
CLRFLXC295
JOHNSON & JOHNSON SURGICAL VISION, INC.
SIL 13.0MM 6 OPT MOD C PMMA OPTIEDGE II
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? |
---|---|---|---|---|
35658 | Posterior-chamber intraocular lens, pseudophakic |
An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. Disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HQL | intraocular lens |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 45 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 13 Millimeter |
Device Record Status
e6ce2c44-5dab-4023-a6d4-2f529f21bd37
July 08, 2021
5
June 30, 2015
July 08, 2021
5
June 30, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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