AccessGUDID - DEVICE: BIONIX RADIATION THERAPY (00817740020416)

GUDID

Device Identifier (DI) Information

Brand Name: BIONIX RADIATION THERAPY
Version or Model: EMRT-8455
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EMRT-8455
Company Name: Bionix Radiation Therapy, LLC

Primary DI Number: 00817740020416
Issuing Agency: GS1
Commercial Distribution End Date: October 30, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080397923 *Terms of Use

Device Description: 3.2MM PERF: 9X12 PUNCHED ON 9"SIDE

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:	Yes
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?
58757	Spine thermoplastic splint system	An assembly of non-sterile devices designed to produce a thermoformable splint intended to be applied externally to the spine of a patient who requires support or immobilization (e.g., to treat fractures, injuries, sprains). It typically consists of a low-temperature thermoplastic material and a textile (e.g., cotton) in the form of the spine and into which the thermoplastic is inserted; the combination is warmed in a water bath for adaptability to the shape of the patient?s spine. It is available in various dimensions and may be used in various clinical specialties. This is a single-patient device that may be reapplied over a short term (single-use) before being discarded.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, linear, medical

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: 4bed89b1-72c9-4d79-afa9-49888f2b9be9
Public Version Date: July 10, 2023
Public Version Number: 5
DI Record Publish Date: April 25, 2017