BIONIX RADIATION THERAPY ERB-90-FS

GUDID 10817740021014

ENDORECTAL BALLOON

BIONIX RADIATION THERAPY, LLC

Prostate immobilization balloon catheter

• Primary Device ID: 10817740021014
• NIH Device Record Key: 876fd4b0-f8ff-44dd-bc03-3effa2ac6488
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIONIX RADIATION THERAPY
• Version Model Number: ERB-90-FS
• Catalog Number: ERB-90-FS
• Company DUNS: 080397923
• Company Name: BIONIX RADIATION THERAPY, LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx

Device Dimensions

• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Outer Diameter: 41.5 Millimeter
• Length: 90 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT
• Special Storage Condition, Specify: Between 0 and 0 *STORE IN A COOL, DRY ENVIRONMENT

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817740021017 [Primary]
GS1	10817740021014 [Package]; Contains: 00817740021017; Package: box [12 Units]; In Commercial Distribution

FDA Product Code

• PCT: Prostate immobilizer rectal balloon

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-04-25

On-Brand Devices [BIONIX RADIATION THERAPY]

• 00817740021208: VERSABOARD ACCESSORY ADAPTER
• 00817740021178: CF MEDICAL INTELLIGENCE SECUREFIT BAR
• 00817740021062: MoldCare Locator Device
• 00817740021055: SecureVac Foot Switch
• 10817740021045: 3.2MM HEAD ONLY FREEVIEW VERSAFRAME SECUREFRAME
• 10817740021038: Standard TruGuard
• 10817740021014: ENDORECTAL BALLOON
• 10817740021007: ENDORECTAL BALLOON
• 00817740020997: ESOPHAGEAL APPLICATOR
• 00817740020980: ESOPHAGEAL APPLICATOR
• 00817740020973: ANORECTAL APPLICATOR
• 00817740020966: ANORECTAL APPLICATOR
• 00817740020959: PRONE BREAST: Large Opening
• 10817740020949: LARGE TRUGUARD
• 00817740020935: CARBON FIBER BUTTERFLY BOARD
• 00817740020928: MAX 3 PLUS
• 00817740020911: CARBON FIBER SECUREFIT BAR
• 00817740020904: NARROW EXTENDED BUTTERFLY BOARD
• 00817740020898: BUTTERFLY BOARD
• 00817740020881: MAX 2 SECUREFIT ARM SUPPORT
• 00817740020874: UPPER ARM SUPPORT-RIGHT
• 00817740020867: UPPER ARM SUPPORT-LEFT
• 00817740020850: ARM SUPPORT
• 00817740020843: ELEKTA SECUREFIT BAR
• 00817740020836: SIEMENS SECUREFIT BAR
• 00817740020829: SECUREFIT SLIDER ATTACHMENT
• 00817740020812: SECUREVAC ADAPTOR
• 00817740020805: VARIAN SECURE FIT BAR
• 00817740020799: NUCLETRON BAR
• 00817740020782: GE SECUREFIT BAR
• 00817740020775: PHILLIPS SECUREFIT BAR
• 00817740020768: 4D 70X70CM, 20L BLACK CUSHION
• 00817740020751: 4D 100X70CM, 35L BLACK CUSHION
• 00817740020744: 4D 100X100CM, 50L BLACK CUSHION
• 00817740020737: 70X50CM 15L SECUREVAC CUSHION
• 00817740020720: HEAD & SHOULDER 10L CUSHION
• 00817740020713: TRIVAC WITH BOLSTER CUSHION
• 00817740020706: 70X70CM, 20L SECUREVAC CUSHION
• 00817740020690: T-VAC SECUREVAC CUSHION
• 00817740020683: TRIVAC WITHOUT BOLSTER CUSHION
• 00817740020676: 100X100CM, 50L SECUREVAC CUSHION
• 00817740020669: 100X150CM, 80L SECUREVAC CUSHION
• 00817740020652: 100X70CM, 35L PELIVC PORTAL SECUREVAC CUSHION
• 00817740020645: 2.5L FILL EXT SECUREVAC CUSHION
• 00817740020638: 32X5X9CM, 2L VERSACUSHION
• 00817740020621: 150CM X 70 CM, 55L SECUREVAC
• 00817740020614: SECUREVAC ADAPTOR FOR HOSPITAL VAC
• 00817740020607: SECUREVAC HOSE ADAPTOR
• 00817740020591: SECUREVAC BOX
• 00817740020584: T-FORM SECUREVAC BOX ADAPTOR