AccessGUDID - DEVICE: IA-12LD/HS13 (04540217032020)

GUDID

Device Identifier (DI) Information

Brand Name: IA-12LD/HS13
Version or Model: 532-16885-65
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SHIMADZU CORPORATION

Primary DI Number: 04540217032020
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690558747 *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?
15963	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.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K012424	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: 96a31cd5-199d-4801-a28a-fbd8857c2916
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016

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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