AccessGUDID - DEVICE: Luneau (03664188000138)

GUDID

Device Identifier (DI) Information

Brand Name: Luneau
Version or Model: Tonometer separation prisms L900 -box of 20
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LUNEAU TECHNOLOGY OPERATIONS

Primary DI Number: 03664188000138
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 260432380 *Terms of Use

Device Description: The separation prisms is an accessory to the tonometer which is device intended to estimate intraocular pressure by applying a force on the globe of the eye.

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?
45750	Ophthalmic tonometer tip cover	A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. It is made of natural rubber latex or synthetic polymer materials. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKY	Tonometer, Manual

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K023838	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ed4a9b04-4d56-444f-a6a2-c9f1d6019d6e
Public Version Date: January 15, 2025
Public Version Number: 3
DI Record Publish Date: June 08, 2023