UTAS UTAS

GUDID 00857901006491

L K C TECHNOLOGIES, INC.

Electroretinograph

• Primary Device ID: 00857901006491
• NIH Device Record Key: ea152c02-3c18-4c81-9072-c0f61ecdfee9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTAS
• Version Model Number: UTAS System Type-9L
• Catalog Number: UTAS
• Company DUNS: 606234730
• Company Name: L K C TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com
• Phone: 301-840-1992
• Email: support@lkc.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857901006491 [Primary]

FDA Product Code

• GWE: Stimulator, Photic, Evoked Response

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-05
• Device Publish Date: 2022-06-27

On-Brand Devices [UTAS]

• 00857901006309: UTAS System Type-62
• 00857901006293: 4CH/AC, BigShot, UV, CRT
• 00857901006286: UTAS System Type-72
• 00857901006279: UTAS System Type-62
• 00857901006262: UTAS System Type-98
• 00857901006255: UTAS System Type-10
• 00857901006248: UTAS System Type-39
• 00857901006231: 4-channel AC Coupled UBA
• 00857901006224: UTAS System Type-35
• 00857901006217: UTAS System Type-48
• 00857901006200: UTAS System Type-40
• 00857901006194: UTAS System Type-14
• 00857901006187: UTAS System Type-16
• 00857901006170: UTAS System Type-12
• 00857901006088: UTAS System Type-9
• 00857901006354: 6CH Pattern/Multi-Focal Only
• 00857901006378: UTAS System Type-10
• 00857901006422: UTAS System Type-54 Dark Adapt
• 00857901006415: UTAS System Type-53 Pattern/Multifocal/SunBurst/RE
• 00857901006408: UTAS System Type-52 Pattern/Multifocal/SunBurst
• 00857901006392: UTAS System Type-51 Pattern/Multifocal/RETeval
• 00857901006385: UTAS System Type-50 Pattern/Multifocal
• 00857901006606: 6CH Pattern/Multi-Focal Only
• 00857901006590: UTAS System Type-52L Pattern/Multifocal/SunBurst
• 00857901006583: UTAS System Type-50L Pattern/Multifocal
• 00857901006576: UTAS System Type-48L
• 00857901006569: 4CH/AC, BigShot, UV, CRT
• 00857901006552: UTAS System Type-41L
• 00857901006545: UTAS System Type-40L
• 00857901006538: UTAS System Type-39L
• 00857901006521: UTAS System Type-12L
• 00857901006514: UTAS System Type-11L
• 00857901006507: UTAS System Type-10L
• 00857901006491: UTAS System Type-9L