AccessGUDID - DEVICE: Artificial Eye (G542V26230)

GUDID

Device Identifier (DI) Information

Brand Name: Artificial Eye
Version or Model: V2623
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: THE EYE CONCERN, INC.

Primary DI Number: G542V26230
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 199692406 *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):	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?
42522	Eyeball prosthesis, custom-made	An artificial substitute for the eyeball, resembling the anterior portion of the eye, made to individual specifications. It is usually constructed of glass or plastic and is intended to be inserted into a patient/user's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. This device is not intended to be implanted.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQH	Eye, Artificial, Non-Custom

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: de5d27b6-8720-4b21-8a56-915a0c5077e6
Public Version Date: January 18, 2024
Public Version Number: 1
DI Record Publish Date: January 10, 2024

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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