AccessGUDID - DEVICE: Automated Ophthalmics Softips (00860000603805)

GUDID

Device Identifier (DI) Information

Brand Name: Automated Ophthalmics Softips
Version or Model: AO316
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: AUTOMATED OPHTHALMICS, INC.

Primary DI Number: 00860000603805
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929977858 *Terms of Use

Device Description: A device that is applied to the tip of a contact type tonometer in order to avoid cross-infection between patients. The device is made of plastic. This is a single-use device.

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):	No
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 [?]
K992998	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 35 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e00ec0bd-f4bc-4b22-b4f1-71efbd2a47a9
Public Version Date: December 11, 2024
Public Version Number: 2
DI Record Publish Date: November 17, 2022