AccessGUDID - DEVICE: SRO 33100 ROT 360 (00884838076358)

GUDID

Device Identifier (DI) Information

Brand Name: SRO 33100 ROT 360
Version or Model: 9890-000-86101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9890-000-86101
Company Name: Philips Medical Systems DMC GmbH

Primary DI Number: 00884838076358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314101218 *Terms of Use

Device Description: diagnostic x-ray tube housing assembly

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?
35618	X-ray tube housing assembly, diagnostic	A metallic (e.g., steel, aluminium alloy) case that houses an x-ray tube to provide appropriate limits for x-ray leakage and adequate insulation to avoid electric risks during a diagnostic x-ray procedure. It includes sheet lead surrounds at appropriate locations to shield unwanted x-ray radiation and collimators near the aperture; it is usually filled with oil to prevent electrical arcs from the high-voltage components of the x-ray tube. The housing also includes attachment points, cooling means, high-voltage cables, and supports for the tube and cable receptacles. It may be an independent unit mounted in a tube support, or under a fluoroscopic table as a component of a radiographic system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITY	Assembly, tube housing, x-ray, diagnostic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: a6f5693f-5641-4199-8a87-a2caa4e2fb15
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 09, 2019