AccessGUDID - DEVICE: AlignRT Plus (05056190500481)

GUDID

Device Identifier (DI) Information

Brand Name: AlignRT Plus
Version or Model: Horizon camera
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VISION RT LIMITED

Primary DI Number: 05056190500481
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 222160801 *Terms of Use

Device Description: Horizon camera pod

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):	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?
47816	Radiological video camera patient positioning/tracking system	An assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radiation treatment planning, and/or radiation therapy without the use of patient markers. It includes a camera(s), workstation, and appropriate software.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203387	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: 6e849740-8167-47c0-88b6-46582bf13608
Public Version Date: December 15, 2022
Public Version Number: 2
DI Record Publish Date: September 23, 2021

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

[?]

Phone: +1 866 594 5443
Email: info@visionrt.com

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