Mammotome HydroMARK

GUDID 10841911102431

HydroMARK Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10841911102431
• NIH Device Record Key: 009c30d0-b073-4222-bf71-dbf5b302591a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mammotome HydroMARK
• Version Model Number: 4010-05-10-T3
• Company DUNS: 961832156
• Company Name: DEVICOR MEDICAL PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Customer Support Contacts

• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com
• Phone: 877-926-2666
• Email: customersupport@mammotome.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911102434 [Primary]
GS1	10841911102431 [Package]; Contains: 00841911102434; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203097

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-10
• Device Publish Date: 2022-03-02

On-Brand Devices [Mammotome HydroMARK]

• 10841911102318: HydroMARK Breast Biopsy Site Marker
• 10841911102301: HydroMARK Breast Biopsy Site Marker
• 10841911102479: HydroMARK Breast Biopsy Site Marker
• 10841911102462: HydroMARK Breast Biopsy Site Marker
• 10841911102448: HydroMARK Breast Biopsy Site Marker
• 10841911102431: HydroMARK Breast Biopsy Site Marker
• 10841911102424: HydroMARK Breast Biopsy Site Marker
• 10841911102394: HydroMARK Breast Biopsy Site Marker