AccessGUDID - DEVICE: MACHIDA (04580137730279)

GUDID

Device Identifier (DI) Information

Brand Name: MACHIDA
Version or Model: LY-CS30
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MACHIDA ENDOSCOPE CO.,LTD.

Primary DI Number: 04580137730279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690662549 *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):	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?
12294	Laryngostroboscope	A device that is intended to allow the observation of glottic action during phonation (speech) in the examination of voice disorders. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. It can contain a microphone that captures the acoustic signals from the glottic area and may or may not contact the patient.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EQL	Laryngostroboscope

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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Handling Environment Humidity: between 30 and 70 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between 10 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 323ee066-6093-4cf6-b133-35f49ec78f1a
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 09, 2023

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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