AccessGUDID - DEVICE: Ocu-Film + (00812559010115)

GUDID

Device Identifier (DI) Information

Brand Name: Ocu-Film +
Version or Model: 230651
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: REICHERT, INC.

Primary DI Number: 00812559010115
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 126650253 *Terms of Use

Device Description: Single use tonometer tip cover used with Tono-Pen tonometers. Used to protect the transducer from dust and fluids, and helps protect patients from risk of cross-contamination.

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):	Yes
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 [?]
K070534	000

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: 7219b8e8-dbcc-454d-8d69-656baa1fb4a2
Public Version Date: October 01, 2025
Public Version Number: 6
DI Record Publish Date: September 22, 2016