AccessGUDID - DEVICE: IA-16LM/HS (04540217020126)

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Device Identifier (DI) Information

Brand Name: IA-16LM/HS
Version or Model: 532-16725-01
Catalog Number:
Company Name: SHIMADZU CORPORATION

Primary DI Number: 04540217020126
Issuing Agency: GS1
Device Count: 1

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

GMDN Preferred Term Name	GMDN Definition
X-ray image intensifier	A device that converts an x-ray image into a light image, then to an electronic image and finally back to a light-based image of diminished size and increased brightness. It consists of a large evacuated glass envelope with four basic parts: 1) an input phosphor/fluorescent screen; 2) a photocathode; 3) an electrostatic focusing lens; and 4) an accelerating anode and output phosphor/fluorescent screen. This GMDN code includes single, dual and triple field intensifier designs. It is primarily used in fluoroscopic, angiographic, cine-fluorographic x-ray, and digital x-ray applications as it outputs an image small enough to be coupled to cine, television or spot-film cameras.

GMDN Preferred Term Name

GMDN Definition

X-ray image intensifier

A device that converts an x-ray image into a light image, then to an electronic image and finally back to a light-based image of diminished size and increased brightness. It consists of a large evacuated glass envelope with four basic parts: 1) an input phosphor/fluorescent screen; 2) a photocathode; 3) an electrostatic focusing lens; and 4) an accelerating anode and output phosphor/fluorescent screen. This GMDN code includes single, dual and triple field intensifier designs. It is primarily used in fluoroscopic, angiographic, cine-fluorographic x-ray, and digital x-ray applications as it outputs an image small enough to be coupled to cine, television or spot-film cameras.

FDA Product Code

[?]

Product Code	Product Code Name
JAA	System, X-Ray, Fluoroscopic, Image-Intensified

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 16, 2016
Commercial Distribution End Date:

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

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DEVICE: IA-16LM/HS (04540217020126)