Posicast® Thermoplastic 930145

GUDID 00841439101759

LPR5 Microperfo mask with profiles

MEDTEC, INC.

Patient positioning thermoplastic mould material

• Primary Device ID: 00841439101759
• NIH Device Record Key: df771603-b19c-4dcf-a40a-cb94c26a8f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Posicast® Thermoplastic
• Version Model Number: 930145
• Catalog Number: 930145
• 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: 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

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 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 0 and 100 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439101759 [Package]; Contains: 10841439101756; Package: [10 Units]; In Commercial Distribution
GS1	10841439101756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060737

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: 6
• Public Version Date: 2020-04-01
• Device Publish Date: 2017-09-25

On-Brand Devices [Posicast® Thermoplastic]

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• 00841439101841: LPRL non-perfo mask with profiles
• 00841439101834: LPR31 Microperfo mask with profiles
• 00841439101827: Disposable non-sterile PR5 Posicast® Non-Perfo mask
• 00841439101766: LPR3 Multiperfo mask with profiles
• 00841439101759: LPR5 Microperfo mask with profiles
• 00841439101742: LPR8 Microperfo mask with profiles
• 00841439101735: LPR55 Microperfo mask with profiles
• 00841439101728: LPR44 Microperfo mask with profiles
• 00841439101711: LPR33 Microperfo mask with profiles
• 00841439101704: LPR3 Microperfo mask with profiles
• 00841439101698: PL4392 Microperfo sheet
• 00841439101681: PR5 Microperfo mask
• 00841439101674: PR44 Microperfo mask
• 00841439101667: PR33 Microperfo mask
• 00841439101650: PR3 Microperfo mask
• 00841439101643: PL4392 Microperfo sheet
• 00841439101636: PR5 Microperfo mask
• 00841439101629: PR44 Microperfo mask
• 00841439101612: PR3 Microperfo mask
• 00841439101605: PL4392 Multiperfo sheet
• 00841439101599: PR5 Multiperfo mask
• 00841439101582: PR3 Multiperfo mask
• 00841439101575: LPR5 Microperfo mask with profiles
• 00841439101568: LPR44 Microperfo mask with profiles
• 00841439101551: LPR3 Microperfo mask with profiles
• 00841439101544: PR5 Microperfo mask
• 00841439101537: PR44 Microperfo mask
• 00841439101520: PR33 Microperfo mask
• 00841439101513: PR3 Microperfo mask
• 00841439101506: Disposable non-sterile PR2 Posicast® Lite Microperfo mask
• 00841439101490: PR5 Multiperfo mask
• 00841439101483: PR3 Multiperfo mask
• 00841439101797: LPR5 Multiperfo mask with profiles