AccessGUDID - DEVICE: Ultrasonic Biometer for Ophthalmology (06948941111109)

GUDID

Device Identifier (DI) Information

Brand Name: Ultrasonic Biometer for Ophthalmology
Version or Model: MD-1000A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Meda Co., Ltd

Primary DI Number: 06948941111109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 545188828 *Terms of Use

Device Description: MD-1000A Ultrasonic Biometer for Ophthalmology is an ultrasonic measuring medical device based on pulse reflection. It’s intended for measurements of biometric parameters.

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?
11389	Ophthalmic ultrasound imaging system	An assembly of mains electricity (AC-powered) devices designed for ophthalmic imaging procedures. It includes software that supports a variety of static and real-time eye and orbital imaging applications including physical measurement and oncology related treatment. It will generate ultrasound pulses, direct them to a target area, detect the resulting ultrasound echoes, and process the resulting information producing and displaying static or dynamic two- or three-dimensional (3-D) images. This GMDN code includes ultrasound imaging systems with, e.g., A-mode, B-mode, Doppler, colour Doppler (CD), M-mode, and duplex (combination imaging, Doppler and/or colour flow) scanning capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYO	System, Imaging, Pulsed Echo, Ultrasonic
ITX	Transducer, Ultrasonic, Diagnostic

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
No Device Sizes

Device Record Status

Public Device Record Key: 0ed45f73-7ad0-4a2d-8dbf-15b3667c0e63
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016