AccessGUDID - DEVICE: MARCO (06909071671048)

GUDID

Device Identifier (DI) Information

Brand Name: MARCO
Version or Model: MARCO ENCORE MANUAL CHAIR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: TAKAGI SEIKO CO.,LTD.

Primary DI Number: 06909071671048
Issuing Agency: GS1
Commercial Distribution End Date: October 24, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 690907167 *Terms of Use

Device Description: No description.

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:	Yes
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?
15723	Ophthalmic chair, line-powered	A mains electricity (AC-powered) device designed to position a patient in a seated or reclined posture for easy access and patient comfort during an ophthalmic examination, treatment, or surgical intervention. It will typically have powered raise/lower functions and may be freestanding or connected to another device or system. It is not designed to position the patient completely horizontally during surgery (i.e., it is not an operating table).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HMD	Chair, Ophthalmic, Manual

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
Handling Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Handling Environment Temperature: between 10 and 35 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0a4506e9-b02b-44d0-9b02-826d3c6014b0
Public Version Date: October 24, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016