AccessGUDID - DEVICE: Orascoptic - Endeavour XL Headlight System (00615375009482)

GUDID

Device Identifier (DI) Information

Brand Name: Orascoptic - Endeavour XL Headlight System
Version or Model: 910119-65
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: METREX RESEARCH, LLC

Primary DI Number: 00615375009482
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 145963778 *Terms of Use

Device Description: NA

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?
32037	General-purpose light source	A mains electricity (AC-powered) device designed to produce light of high intensity, often called cold light, for various patient examination and procedure applications. Light transfer occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., headlight, microscope, or endoscope).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBA	LIGHT, SURGICAL HEADLIGHT

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
Special Storage Condition, Specify: Store at Temperature of -4F to 104F; Relative Humidity of 10 to 85; Atmospheric Pressure of 0.5 atm to 1.0 atm

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: caedbacc-9327-4d8f-acad-d445f9c1458f
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022