Vac-Lok™ Cushion VLARM01

GUDID 00841439112069

Reusable non-sterile clear urethane bag (75 x 75cm, 20L) for arms-up positioning

MEDTEC, INC.

Vacuum-mould patient positioning system

• Primary Device ID: 00841439112069
• NIH Device Record Key: d989c7bb-3656-4493-bbc7-0d2e1da98c6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vac-Lok™ Cushion
• Version Model Number: VLARM01
• Catalog Number: VLARM01
• 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: 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
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com
• Phone: +1(712)737-8688
• Email: radiotherapy.complaints@civcort.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439112069 [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: 4
• Public Version Date: 2019-05-31
• Device Publish Date: 2018-05-07

On-Brand Devices [Vac-Lok™ Cushion]

• 00841439112472: "L" shaped nylon bag (80 x 90cm, 28L)
• 00841439112458: T shape nylon bag (108 x 125cm x 42L)
• 00841439112427: Nylon bag (60 x 100.5cm, 15L) with indexing for pelvic positioning
• 00841439112410: Nylon bag (100 x 150cm, 80L)
• 00841439112403: Nylon bag (100 x 100cm, 40L)
• 00841439112397: Nylon bag (25 x 50cm, 2.25L)
• 00841439112380: Nylon bag (50 x 70cm, 15L)
• 00841439112373: Nylon bag (75 x 150cm, 50L)
• 00841439112366: Nylon bag (70 x 100cm, 35L)
• 00841439112359: Nylon bag (70 x 100cm, 40L)
• 00841439112342: Nylon bag (100 x 200cm, 120L)
• 00841439112335: Reusable non-sterile nylon bag (70 x 70cm, 20L)
• 00841439112328: (75 x 120cm, 34L) nylon bag for pelvic positioning
• 00841439112311: 75 x 100cm, 28L, nylon bag for pelvic positioning
• 00841439112304: Nylon bag (55 x 88cm, 15L) for wingboard
• 00841439112298: "L" shaped nylon bag (80 x 100cm, 34L)
• 00841439112281: Reusable non-sterile nylon bag (75 x 75cm, 20L) for arms-up positioning
• 00841439112274: Reusable non-sterile nylon bag (75 x 105cm, 28L) for arms-up positioning
• 00841439112267: (80 x 100cm, 28L) hourglass shaped nylon bag for pelvic positioning
• 00841439112250: "T" shape nylon bag (108 x 125cm, 44L)
• 00841439112243: Nylon bag with indexing (100 x 100cm, 40L)
• 00841439112236: Nylon bag with indexing (50 x 70cm, 15L)
• 00841439112229: Nylon bag with indexing (75 x 150cm, 50L)
• 00841439112205: Nylon bag with indexing (70 x 100cm, 35L)
• 00841439112199: Nylon bag with indexing (70 x 100cm, 40L)
• 00841439112182: Nylon bag with indexing (70 x 70cm, 20L)
• 00841439112175: Nylon bag (75 x 100cm, 28L) with indexing for pelvic positioning
• 00841439112168: Nylon bag (75 x 120cm, 34L) with indexing for pelvic positioning
• 00841439112151: "T" shaped nylon bag (87.5 x 140cm, 25L)
• 00841439112137: Reusable non-sterile nylon bag (75 x 75cm, 20L) with indexing for arms-up positioning
• 00841439112120: Reusable non-sterile nylon bag (75 x 105cm, 28L) with indexing for arms-up positioning
• 00841439112106: Type-S™ nylon bag (61 x 65cm, 8L) with indexing
• 00841439112090: Type-S™ nylon bag (140 x 65cm, 27L) with indexing
• 00841439112083: "L" shaped clear urethane bag (80 x 100cm, 34L)
• 00841439112076: "T" shaped clear urethane bag (50 x 70cm, 6L)
• 00841439112069: Reusable non-sterile clear urethane bag (75 x 75cm, 20L) for arms-up positioning
• 00841439112052: Reusable non-sterile clear urethane bag (75 x 105cm, 28L) for arms-up positioning
• 00841439112045: Clear urethane bag (100 x 100cm, 40L)
• 00841439112038: Clear urethane bag (25 x 50cm, 2.25L)
• 00841439112021: Clear urethane bag (50 x 70cm, 15L)
• 00841439112014: Clear urethane bag (75 x 150cm, 50L)
• 00841439112007: Clear urethane bag (70 x 100cm, 35L)
• 00841439111994: Clear urethane bag (70 x 100cm, 40L)
• 00841439111987: Clear urethane bag (70 x 70cm, 20L)
• 00841439111970: 75 x 100cm, 28L, clear urethane bag for pelvic positioning
• 00841439111963: (75 x 120cm, 34L) clear urethane bag for pelvic positioning
• 00841439111956: Clear urethane bag (55 x 88cm, 15L) for wingboard
• 00841439108673: Reusable, non-sterile, 55 x 88cm, 15L, clear urethane bag for wingboard safe for use in 1.5T and
• 00841439108666: 140 x 65cm, 27L, Type-S™ nylon bag with indexing
• 00841439108635: 80 x 100cm, 28L, hourglass shaped nylon bag for pelvic positioning