AccessGUDID - DEVICE: ELECTROGLOTTOGRAPH (04961333229888)

GUDID

Device Identifier (DI) Information

Brand Name: ELECTROGLOTTOGRAPH
Version or Model: 6103
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PENTAX OF AMERICA, INC.

Primary DI Number: 04961333229888
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083211284 *Terms of Use

Device Description: KayPentax Electroglottograph

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?
16034	Electroglottograph	A graphic recorder designed for recording the changes in electrical potential or impedance, using a sensor, resulting from movement of the vocal cords during respiration and phonation. It is intended to be used to asses the degree of closure of the vocal cords during treatment of voice disorders and in the study of the laryngeal mechanism.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLX	Electroglottograph

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K990240	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
Special Storage Condition, Specify: 10-40 degrees Celsius, 30-90% humidity, 700-1060 millibars air pressure

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 808d5a9b-8904-4534-b3fd-5e1bfa407bea
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: April 06, 2017

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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