AccessGUDID - DEVICE: IS-5500 (00852683007117)

GUDID

Device Identifier (DI) Information

Brand Name: IS-5500
Version or Model: 23060-11-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TOPCON HEALTHCARE INC

Primary DI Number: 00852683007117
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 053547238 *Terms of Use

Device Description: IS-5500 OPHTHALMIC INST. STAND W/DLRL 11; AC-Powered Ophthalmic Instrument Stand

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?
36255	Static ophthalmic equipment stand, manually-adjusted	A device designed as a column or post, usually with a small flat surface top, used to provide support and position control for ophthalmic devices commonly used during an ophthalmic examination/treatment (e.g., a slit lamp, keratometer, refractometer). It may have a manually-operated height adjustment function (e.g., a hydraulic foot pump or adjustable threaded column) enabling the user to align (raise/lower) the ophthalmic instruments to the eye level of the patient. It is typically stationary and may have drawers, shelves, and built-in outlets to supply low-voltage electricity to the instruments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMF	Stand, Instrument, Ac-Powered, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 03db6796-c1e7-4b2a-892f-aa7a31eedb7d
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: December 07, 2022