AccessGUDID - DEVICE: iLumin (00893872001608)

GUDID

Device Identifier (DI) Information

Brand Name: iLumin
Version or Model: FI-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 205000
Company Name: Nova Eye, Inc.

Primary DI Number: 00893872001608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079755637 *Terms of Use

Device Description: Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions

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?
65935	Ophthalmic procedural light source unit	An electrically-powered, noninvasive device designed to produce light of high intensity, often called cold light, for ophthalmic examination and procedure applications. It is designed as a portable unit with controls whereby light transmission occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., fibreoptic probes and micro light-conducting ophthalmic instruments that provide intraocular illumination).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPA	Endoilluminator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K062259	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
Handling Environment Temperature: between -30 and 50 Degrees Celsius
Storage Environment Temperature: between -30 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d27262f-f054-42bf-a38a-4fbbb67021b7
Public Version Date: July 29, 2024
Public Version Number: 1
DI Record Publish Date: July 19, 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

[?]

Phone: 1-510-291-1300
Email: iTrack@nova-eye.com

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