AccessGUDID - DEVICE: Huestis Medical Collimator (00850077007149)

GUDID

Device Identifier (DI) Information

Brand Name: Huestis Medical Collimator
Version or Model: CM-3201-101
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HUESTIS MACHINE CORPORATION

Primary DI Number: 00850077007149
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001188390 *Terms of Use

Device Description: 150PBL/SC Thin Mirror Collimator, ( Huestis Part # CM-3201-201 )

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?
33136	Automatic-aperture-control diagnostic x-ray system collimator	A standard, diagnostic x-ray beam-limiting and shaping device that includes an automatically controlled motorized shutter mechanism. It is designed to adjust the shutters so that the x-ray beam shape matches the size of the film cassette in the holder and is attached to the beam exit port of a diagnostic x-ray system tube housing assembly. It typically includes a light-centring device that is used to project a light field onto the patient that is coincident with the x-ray beam in order to centre the tube over the film cassette. It is used to limit the effects of scattered radiation on image quality and to provide patient protection by eliminating exposure to non-target body areas.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZX	Collimator, Manual, Radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972966	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: a0c70a49-b531-45aa-949c-40e9c8af6eeb
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 05, 2016