BIONIX RADIATION THERAPY EMRT-8300

GUDID 10817740020079

2.4MM 10X10, STANDARD U-FRAME

BIONIX RADIATION THERAPY, LLC

Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system Spine thermoplastic splint system

• Primary Device ID: 10817740020079
• NIH Device Record Key: 6d5ab09e-5e8c-4502-b0d8-49f2c3a008b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIONIX RADIATION THERAPY
• Version Model Number: EMRT-8300
• Catalog Number: EMRT-8300
• 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: false
• 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
• Phone: +1(800)624-6649
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817740020072 [Primary]
GS1	10817740020079 [Package]; Contains: 00817740020072; Package: box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120335

FDA Product Code

• LGF: Component, cast

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• 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