Thermoplastic MTBBA1522S

GUDID 00841439103906

Disposable non-sterile (39.4 x 55.9cm) solid perforated thermoplastic (3.2mm)

MEDTEC, INC.

Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material Patient positioning thermoplastic mould material

• Primary Device ID: 00841439103906
• NIH Device Record Key: 392c023e-ff63-47fb-b6a8-7555f33ed5e6
• Commercial Distribution Discontinuation: 2019-05-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Thermoplastic
• Version Model Number: MTBBA1522S
• Catalog Number: MTBBA1522S
• 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: 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
• 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

Device Dimensions

• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch
• Length: 22 Inch

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
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 52 Degrees Fahrenheit and 85 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439103906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080072

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: 2019-05-20
• Device Publish Date: 2017-09-22

On-Brand Devices [Thermoplastic]

• 00841439103906: Disposable non-sterile (39.4 x 55.9cm) solid perforated thermoplastic (3.2mm)
• 00841439103371: Disposable non-sterile (61 x 91.4cm) standard perforated thermoplastic (2.4mm)
• 00841439103173: 3.5 x 35cm thermoplastic strip (3.2mm)
• 00841439103159: 3.5 x 25cm thermoplastic strip (3.2mm)
• 00841439107171: 45.7 x 22.9cm standard perforated breast support thermoplastic (2.4mm)
• 00841439107164: 45.7 x 22.9cm standard perforated breast support thermoplastic (3.2mm)
• 00841439107157: 45.7 x 22.9cm IMRT breast support thermoplastic (2.4mm)
• 00841439107140: 45.7 x 22.9cm IMRT breast support thermoplastic (3.2mm)
• 00841439103135: 3.5 x 61cm thermoplastic strip (3.2mm)