AccessGUDID - DEVICE: Schioetz Tonometer - Allen Wrench Modification (B091131100)

GUDID

Device Identifier (DI) Information

Brand Name: Schioetz Tonometer - Allen Wrench Modification
Version or Model: 13110
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 13110
Company Name: Gulden Ophthalmics Inc.

Primary DI Number: B091131100
Issuing Agency: HIBCC
Commercial Distribution End Date: June 29, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 002373249 *Terms of Use

Device Description: Manual tonometer used to gauge internal pressure within the eye. An allen wrench can be used to adjust weight settings.

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):	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?
32721	Ophthalmic tonometer, manual	An ophthalmic, manually-operated, measuring instrument designed for determining the intraocular pressure (IOP) by exerting an external force in direct contact with the eye which provides a reading of the resistance of the tunica of the eye to deformation (the extent of corneal indentation) which is expressed in millimetre(s) of mercury (mmHg). This device (known as a contact type, e.g., a Schioetz or Perkins tonometer) is used in the diagnosis of glaucoma and may be hand-held or used in conjunction with a slit lamp.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HKY	Tonometer, Manual

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
Width: 2 Inch
Length: 5.25 Inch

Device Record Status

Public Device Record Key: b686c1c6-4d60-4f46-a285-058627c3b629
Public Version Date: July 03, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016