AccessGUDID - DEVICE: Halogen lamp (04953170078781)

GUDID

Device Identifier (DI) Information

Brand Name: Halogen lamp
Version or Model: MAJ-927
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170078781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: "MAJ-927 HALOGON LAMP FOR MAJ-922"

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Endoscopic light source, battery-powered	A battery-powered device that provides light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes, e.g., laparoscopes, gastroscopes and their accessories. It provides a source of bright light that is channelled via a light cable connecting this device to the endoscope to illuminate the site of observation/intervention while minimizing tissue. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Endoscopic light source, battery-powered

A battery-powered device that provides light of high intensity, often called cold light, for viewing surgical fields and body cavities when using rigid or flexible endoscopes, e.g., laparoscopes, gastroscopes and their accessories. It provides a source of bright light that is channelled via a light cable connecting this device to the endoscope to illuminate the site of observation/intervention while minimizing tissue. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
FDS	Gastroscope and accessories, flexible/rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K002231	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 694bb1f7-b3c4-4dcb-ad01-bf1ecbcfebdc
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2016