AccessGUDID - DEVICE: IDESIGN RS (05050474620278)

GUDID

Device Identifier (DI) Information

Brand Name: IDESIGN RS
Version or Model: G301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0110-3521
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 05050474620278
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010130626 *Terms of Use

Device Description: PACK IN, IDESIGN, VISION TABLE UPGRADE

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
36386	Automated ophthalmic refractometer	An electrically-powered, ophthalmic device designed to be used by a healthcare professional to objectively measure the refractive error of the eye (the inaccuracies of focusing light upon the retina) by measuring how light is changed when it enters the patient's eye(s). The device emits light into the eye and detects the light reflection which is measured for sphere, cylinder, axis and/or high order aberration measurements, typically measured in dioptres (the reciprocal of the focal length of the lens expressed in metres). Also known as an aberrometer, the device uses this information to automatically calculate the lens prescription needed to correct the patient's vision.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZS	Excimer laser system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P930016	053

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -10 and 60 Degrees Celsius
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -10 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4901806c-3081-42d5-93e1-64c1d64b3594
Public Version Date: March 27, 2024
Public Version Number: 4
DI Record Publish Date: August 21, 2018