IPPS™ Overlay MTM3404

GUDID 00841439106754

53cm overlay with Interloc® Lok-Bar™ (2), head extension, coil support, locating blocks (2), and template for use with Philips Ingenia

MEDTEC, INC.

Indexed-immobilization patient positioning system

• Primary Device ID: 00841439106754
• NIH Device Record Key: e074ab72-012a-4304-8ffd-6ea31ac18c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IPPS™ Overlay
• Version Model Number: MTM3404
• Catalog Number: MTM3404
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439106754 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

FDA Product Code

• IYE: Accelerator, linear, medical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-03-12
• Device Publish Date: 2017-08-02

On-Brand Devices [IPPS™ Overlay]

• 00841439106839: 53cm overlay with template for use with Philips Ingenia
• 00841439106822: 53cm overlay with Interloc® Lok-Bar™ (2), head extension, locating blocks (2), and template f
• 00841439106785: Non-sterile reusable 53cm overlay with Interloc® Lok-Bar™ (2), head extension, coil support,
• 00841439106754: 53cm overlay with Interloc® Lok-Bar™ (2), head extension, coil support, locating blocks (2),
• 00841439106747: Non-sterile resuable Panorama 40cm overlay with Prodigy™ Lok-Bar™, supports (4), risers (4),
• 00841439106723: Panorama 40cm overlay with Prodigy™ Lok-Bar™, supports (4), risers (4), adhesive, abrasive p
• 00841439106716: Panorama 50cm overlay with Prodigy™ Lok-Bar™, supports (4), risers (4), adhesive, abrasive p
• 00841439106693: with Lok-Bar™ and coil supports (2)
• 00841439106686: IPPS™ Overlay
• 00841439106662: with Interloc® Lok-Bar™, coil supports (2), and table fillers (2)
• 00841439106655: with GE Signa Table and coil supports (2)
• 00841439106624: For use with Posifix® thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR
• 00841439106594: For use with Type-S™ thermoplastics with Prodigy™ Lok-Bar™ and supports (2) for Siemens MR
• 00841439106570: with Prodigy™ Lok-Bar™ and supports (2) for 58mm slot
• 00841439106549: with Prodigy™ Lok-Bar™ and supports (2) for 50mm slot
• 00841439106198: Canon Aquilion One CT cradle top without extension
• 00841439106174: Canon Aquilion CT cradle top without extension
• 00841439106150: Toshiba Aquilion One CT on piece cradle top
• 00841439106143: Toshiba Aquilion CT one piece cradle top
• 00841439106136: Reusable non-sterile Toshiba Aquilion One CT cradle top
• 00841439106129: Canon Aquilion CT cradle top Head End Support
• 00841439106099: Toshiba Aquilion CT cradle top
• 00841439106075: Philips Brilliance CT cradle top without extension
• 00841439106051: Philips Brilliance CT one piece cradle top
• 00841439106020: Reusable non-sterile Philips Brilliance CT cradle top
• 00841439105979: GE VCT Global 2000 CT cradle top without extension
• 00841439105955: GE VCT Global 1700 CT cradle top without extension
• 00841439105931: GE Discovery STCT cradle top without extension
• 00841439105917: GE Hi-Speed CT cradle top without extension
• 00841439105894: GE VCT Global 2000 CT one piece cradle top
• 00841439105887: GE VCT Global 1700 one piece cradle top
• 00841439105870: GE Discovery STCT one piece cradle top
• 00841439105863: GE Hi-Speed CT one piece cradle top
• 00841439105832: Reusable non-sterile GE VCT Global 2000 CT cradle top
• 00841439105801: Reusable non-sterile GE VCT Global 1700 CT cradle top
• 00841439105764: Reusable non-sterile GE Discovery STCT cradle top
• 00841439105733: Reusable non-sterile GE Hi-Speed CT cradle top
• 00841439105412: Siemens Somotom CT cradle top without extension
• 00841439105313: Siemens Somatom CT one piece cradle top
• 00841439105306: Siemens Biograph PET/CT one piece cradle top
• 00841439105207: Reusable non-sterile Siemens Biograph PET/CT cradle top
• 00841439105108: Siemens Biograph overlay with Interloc® Lok-Bar™
• 00841439105092: Kermath overlay (211 x 53 x 2.2cm) with Interloc® Lok-Bar™
• 00841439105054: Toshiba Aquilion long overlay (231 x 53 x 4.2cm) with Interloc® Lok-Bar™
• 00841439105047: Toshiba AquilionONE overlay, with Prodigy™ Lok-Bar™
• 00841439105030: Toshiba Aquilion long overlay (231 x 53 x 4.2cm) with Interloc® Lok-Bar™
• 00841439105023: Toshiba Aquilion short overlay (201 x 53 x 4.2cm) with Interloc® Lok-Bar™
• 00841439104903: for use with Philips / Marconi MX8000 system
• 00841439104866: for use with Philips GEMINI system
• 00841439104859: for use with Philips GEMINI system