Vac-Lok Cushion MTVLE2.25C

GUDID 00841439108345

Reusable, non-sterile, 25 x 50cm, 2.25L, nylon bag safe for use in 1.5T and 3.0T MR environments

MEDTEC, INC.

Vacuum-mould patient positioning system

• Primary Device ID: 00841439108345
• NIH Device Record Key: cd71fe2b-dd68-410a-b91d-03e76eb8d7d8
• Commercial Distribution Discontinuation: 2019-05-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Vac-Lok Cushion
• Version Model Number: MTVLE2.25C
• Catalog Number: MTVLE2.25C
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Device Dimensions

• Length: 50 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439108345 [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: 5
• Public Version Date: 2019-05-20
• Device Publish Date: 2017-08-02

On-Brand Devices [Vac-Lok Cushion]

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• 00841439108659: Reusable, non-sterile, 61 x 65cm, 8L, Type-S nylon bag with indexing safe for use in 1.5T and 3.
• 00841439108642: Reusable, non-sterile, 80 x 150cm, 35L, nylon bag for pelvic positioning safe for use in 1.5T an
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• 00841439108598: Reusable, non-sterile, 75 x 100cm, 28L, nylon bag with indexing for pelvic positioning safe for
• 00841439108581: Reusable, non-sterile, 75 x 100cm, 28L, nylon bag for pelvic positioning safe for use in 1.5T an
• 00841439108550: Reusable, non-sterile, 70 x 70cm, 20L, nylon bag with indexing safe for use in 1.5T and 3.0T MR
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• 00841439108345: Reusable, non-sterile, 25 x 50cm, 2.25L, nylon bag safe for use in 1.5T and 3.0T MR environments
• 00841439108321: Reusable, non-sterile, 55 x 90cm, 15L, nylon bag for breastboards safe for use in 1.5T and 3.0T
• 00841439108284: Reusable, non-sterile, 100 x 100cm, 40L, nylon bag for safe for use in 1.5T and 3.0T MR environ
• 00841439108253: Reusable, non-sterile, 75 x 105cm, 28L, nylon bag for arms-up positioning safe for use in 1.5T a
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• 00841439108208: Reusable, non-sterile, 100 x 150cm, 80L, nylon bag safe for use in 1.5T and 3.0T MR environments
• 00841439108093: Reusable, non-sterile 108 x 125cm, 44L, T shape nylon bag for use in 1.5T and 3.0T MR environmen
• 00841439108079: Reusable, non-sterile, 80 x 90cm, 28L, "L" shaped nylon bag safe for use in 1.5T and 3.0T MR env
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• 00841439108352: Reusable, non-sterile, 50 x 70cm, 15L, clear urethane bag safe for use in 1.5T and 3.0T MR envir
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