AccessGUDID - DEVICE: OARtrac (00851546007097)

GUDID

Device Identifier (DI) Information

Brand Name: OARtrac
Version or Model: OT-PSS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OT-PSS
Company Name: RADIADYNE, L.L.C.

Primary DI Number: 00851546007097
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005744772 *Terms of Use

Device Description: OARtrac Proprietary System Software for CDU

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?
60320	MOSFET radiation therapy dosimetry system	An assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. It typically consists of several wire-connected MOSFET dosimeters, a portable battery-powered dosimeter reader, and application software; it may include wireless data exchanging technology. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NZT	Dosimeter, Ionizing Radiation, Implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141154	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: dd06a313-147c-497b-95c4-2778b99be0ec
Public Version Date: November 05, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 281-759-9600
Email: leahroe@radiadyne.com

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