BioXmark

GUDID 00841439115114

MEDTEC, INC.

Radiological image marker, implantable

• Primary Device ID: 00841439115114
• NIH Device Record Key: eb80686b-7a81-4124-9bca-9f1ea04131ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioXmark
• Version Model Number: 11210590
• Company DUNS: 103977526
• Company Name: MEDTEC, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep Away from Sunlight
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841439115114 [Primary]
GS1	10841439115111 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN220017

FDA Product Code

• QUV: Phase-Changing Fiducial Marker For Radiation Therapy

Sterilization

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

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

[00841439115114]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-09
• Device Publish Date: 2025-07-01

Devices Manufactured by MEDTEC, INC.

• 00841439114650 - Pronumbra: 2025-09-22 Pronumbra Helping Hand, Left
• 00841439114674 - Pronumbra: 2025-09-22 Pronumbra Helping Hand, Right
• 00841439114681 - Pronumbra: 2025-09-22 Pronumbra 130cm kVue
• 00841439114698 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 40mm
• 00841439114704 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 50mm
• 00841439114711 - Pronumbra: 2025-09-22 Pronumbra Neck Support, 65mm
• 00841439114728 - Pronumbra: 2025-09-22 Pronumbra Shoulder Adapter
• 00841439114841 - ZiFix Traverse: 2025-09-22 ZiFix Traverse with ONEClamp