AccessGUDID - DEVICE: INTRALASE TECHNOLOGY PI (05050474655690)

GUDID

Device Identifier (DI) Information

Brand Name: INTRALASE TECHNOLOGY PI
Version or Model: 0155-1825
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0155-1825
Company Name: JOHNSON & JOHNSON SURGICAL VISION, INC.

Primary DI Number: 05050474655690
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010130626 *Terms of Use

Device Description: ASSY, 20 PACK,PATIENT INTERFACE, STERILE

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?
41707	Laser beam delivery unit holder	A device designed to be used together with a laser delivery unit to provide support to the delivery unit during the operation of the laser. The holder will help with the positioning of the final laser beam output and increase safety from inadvertent movement which would be undesirable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOE	Ophthalmic femtosecond laser

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
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 0 and 55 Degrees Celsius
Handling Environment Temperature: between -10 and 55 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c659d470-a84a-4a59-8712-3ff930767ea8
Public Version Date: August 21, 2023
Public Version Number: 1
DI Record Publish Date: August 11, 2023