AccessGUDID - DEVICE: NA (04582275270020)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: EV-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KONAN MEDICAL USA, INC.

Primary DI Number: 04582275270020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 788439219 *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:	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?
46568	Vision electrophysiology analysis system	An assembly of mains electricity (AC-powered) devices that provides visual stimuli (e.g., patterns of light, images) to a patient to measure, record, and display visual electrophysiologic responses [e.g., electroretinogram (ERG), visual evoked potential (VEP), and electrooculogram (EOG)], typically as an aid in the diagnosis and management of visual disorders involving ocular electrophysiology (EP), e.g., glaucoma. It may involve the use of electrodes placed on the patient's face and eyes, or the use of other devices such as visual stimulation goggles. The system may be used to screen infants and pre-school children for visual disorders without dilation or sedation.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GWE	Stimulator, photic, evoked response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K081591	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: 0fbbed02-abad-440c-b253-2de5d96b6829
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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