AccessGUDID - DEVICE: TECNIS ODYSSEY TORIC II IOL (05050474812710)

GUDID

Device Identifier (DI) Information

Brand Name: TECNIS ODYSSEY TORIC II IOL
Version or Model: DRT300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DRT3000290
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 05050474812710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103021940 *Terms of Use

Device Description: TEC ODYSSEY TOR II SMPCY 29.0D CYL3.00

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
MFK	Lens, multifocal intraocular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP AWAY FROM SUNLIGHT
Storage Environment Temperature: between 5 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: OPTICAL ZONE DIAMETER:6.00 mm
Device Size Text, specify: OPTICAL POWER:29.00 DIO
Device Size Text, specify: CYLINDER POWER:3.00 DIO
Outer Diameter: 13.00 Millimeter

Device Record Status

Public Device Record Key: c919d4fb-fe43-4a92-bc35-4ea524b58a5e
Public Version Date: January 29, 2024
Public Version Number: 1
DI Record Publish Date: January 19, 2024