AccessGUDID - DEVICE: UTAS (00857901006217)

GUDID

Device Identifier (DI) Information

Brand Name: UTAS
Version or Model: UTAS System Type-48
Commercial Distribution Status: In Commercial Distribution
Catalog Number: UTAS
Company Name: L K C TECHNOLOGIES, INC.

Primary DI Number: 00857901006217
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 606234730 *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):	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?
11482	Electroretinograph	An ophthalmic device used to record the changes in electric potential on or near the surface of the cornea to a reference distal point on the body, following stimulation of the retina by light, i.e., flashes of white light. The electroretinograph (ERG) recorder is used with a primary electrode [typically gold (Au), platinum (Pt) or silver (Ag)] and a reference electrode located almost anywhere on the body, e.g., cheek or ear lobe, and an amplifier that boosts the bioelectrical potential. Some are compatible with a personal computer (PC) for waveform storage and analysis. It is used in the diagnosis of retinal degeneration, night blindness, and circulatory disturbances of the retina.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GWE	Stimulator, Photic, Evoked Response

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: df7eef08-ee3d-43e4-b3ce-3ec7ee0861d6
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 09, 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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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