AccessGUDID - DEVICE: Eyelite, Alcon (00380655011010)

GUDID

Device Identifier (DI) Information

Brand Name: Eyelite, Alcon
Version or Model: 8065-5011-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380655011010
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: Eyelite Slitlamp Adaptation

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:	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?
36184	Laser adaptor	A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQF	Laser, ophthalmic

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d41d30ca-6772-46a6-9c7f-d0e7b34f9b23
Public Version Date: March 22, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2016