AccessGUDID - DEVICE: System Table (04987669101483)

GUDID

Device Identifier (DI) Information

Brand Name: System Table
Version or Model: ST-6100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NIDEK CO.,LTD.

Primary DI Number: 04987669101483
Issuing Agency: GS1
Commercial Distribution End Date: March 29, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 690635461 *Terms of Use

Device Description: The ST-6100 is the system table on which the Nidek Refractor RT-6100, RT-3100, or a manually operated refractor such as the RT-600 or SLY-100*1 is installed. The system table allows chart presenting devices (SSC-370, CP-770, SC-1600 series), auto refractometers, lensmeters (LM-1800 series, LM-7 series), and slit lamp (SL-1800 TAKAGI M2/M4) to be combined into an ophthalmic workstation. The system table consists of a refractor head lift arm equipped with a refractor head and a motorized main table. While compact, it includes a motorized table with a stroke up to 180 mm for the up-and-down movement, a one-touch swingable refractor head lift arm, and a drawer that can hold 40 types of trial lenses. Trays for mounting an auto refractometer, or for mounting a slit lamp and auto refractometer are also available.

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):	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?
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: 6145b008-df39-402e-bb4a-c60c3fca82ae
Public Version Date: April 03, 2019
Public Version Number: 1
DI Record Publish Date: March 26, 2019