AccessGUDID - DEVICE: SYSTEM TABLE (04987669100806)

GUDID

Device Identifier (DI) Information

Brand Name: SYSTEM TABLE
Version or Model: ST-5100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669100806
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The ST-5100 is the system table on which the NIDEK REFRACTOR RT-5100 is installed. The table allows the SSC-330/350, AR/ARK series, and LM-500/LM-600 series/LM-1800 series to be combined into an ophthalmic workstation. The table is composed of a refractor arm, motorized main table, and side table. The main table, which is electrically extendable up to 180 mm, has an RT arm, rotatable with one touch, simple operation, and a tray to hold an auto refractometer (AR/ARK series). The side table is for installing the SSC-330/350 or LM-500/LM-600 series/LM-1800 series. It is equipped with drawers for trial lenses and space for a computer and printer.

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?
13959	Instrument table	A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HRJ	Table, Instrument, 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: fe9ae642-4741-4061-8585-a9804b114d10
Public Version Date: May 21, 2018
Public Version Number: 1
DI Record Publish Date: April 20, 2018