AccessGUDID - DEVICE: Collimator Cradle 512 asm (00884838081093)

GUDID

Device Identifier (DI) Information

Brand Name: Collimator Cradle 512 asm
Version or Model: 1024280
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Philips Digital Mammography Sweden AB

Primary DI Number: 00884838081093
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 632899233 *Terms of Use

Device Description: The collimator is intended for a larger compression height range with breasts of larger size.

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":	Yes
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?
42254	Fixed-aperture diagnostic x-ray system collimator	A standard, non-motorized, diagnostic x-ray beam-limiting device that has a fixed size opening. It attaches by means of a slot or base plate to a diagnostic x-ray system tube housing and 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. An aperture diaphragm consists of a sheet of lead with a hole in the middle. The size and shape of the hole determine the size and shape of the x-ray beam exiting from the x-ray system. Cones and cylinders used for beam collimation are made of lead and attach by means of a base plate to an x-ray tube housing assembly.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZW	Collimator, automatic, radiographic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: e99ed7cb-189b-48be-81d7-5999e33237b5
Public Version Date: August 02, 2021
Public Version Number: 4
DI Record Publish Date: September 19, 2016