AccuForm™ Cushion MTACL6060

GUDID 00841439103081

(60 x 60cm)

MEDTEC, INC.

Patient positioning foam mould kit

• Primary Device ID: 00841439103081
• NIH Device Record Key: c243d424-75d0-4085-96d0-fd29411d7fb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuForm™ Cushion
• Version Model Number: MTACL6060
• Catalog Number: MTACL6060
• 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: false
• Manufacturing Date: true
• 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(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439103081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093738

FDA Product Code

• LNH: System, nuclear magnetic resonance imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-08-20
• Device Publish Date: 2017-08-02

On-Brand Devices [AccuForm™ Cushion]

• 00841439103098: Type-S™
• 00841439103081: (60 x 60cm)
• 00841439103074: (40 x 60cm)
• 00841439103067: (20 x 45cm)
• 00841439103050: (20 x 35cm) chamfered, half fill
• 00841439103043: (20 x 35cm) chamfered
• 00841439103036: (15 x 20cm)
• 00841439103029: (20 x 25cm)
• 00841439114421: Trapezoid
• 00841439114414: (20 x 35cm) Rounded
• 00841439114407: Type-S™
• 00841439114391: Type-S™ Narrow