AccessGUDID - DEVICE: Merge Eye Station (00842000100140)

GUDID

Device Identifier (DI) Information

Brand Name: Merge Eye Station
Version or Model: 11.6.1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MERGE HEALTHCARE SOLUTIONS INC.

Primary DI Number: 00842000100140
Issuing Agency: GS1
Commercial Distribution End Date: August 03, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 065626069 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
41670	Radiological PACS software	An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFJ	System, Image Management, Ophthalmic
HKI	Camera, Ophthalmic, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K913929	000

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: 29dfacc9-9675-439a-b4ba-5f7607922360
Public Version Date: November 06, 2023
Public Version Number: 8
DI Record Publish Date: December 01, 2016