HydroMARK Breast Biopsy Site Marker

GUDID 10841911102165

HydroMARK Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Imaging lesion localization marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 10841911102165
• NIH Device Record Key: c7c63fb3-73fd-49e7-81df-f86786730cb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroMARK Breast Biopsy Site Marker
• Version Model Number: 4010-02-15-T4
• 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: false
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911102168 [Primary]
GS1	10841911102165 [Package]; Contains: 00841911102168; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130537

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

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

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

[10841911102165]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-03-25

On-Brand Devices [HydroMARK Breast Biopsy Site Marker]

• 10841911102257: HydroMARK Breast Biopsy Site Marker
• 10841911102240: HydroMARK Breast Biopsy Site Marker
• 10841911102233: HydroMARK Breast Biopsy Site Marker
• 10841911102226: HydroMARK Breast Biopsy Site Marker
• 10841911102219: HydroMARK Breast Biopsy Site Marker
• 10841911102202: HydroMARK Breast Biopsy Site Marker
• 10841911102196: HydroMARK Breast Biopsy Site Marker
• 10841911102189: HydroMARK Breast Biopsy Site Marker
• 10841911102172: HydroMARK Breast Biopsy Site Marker
• 10841911102165: HydroMARK Breast Biopsy Site Marker
• 10841911102158: HydroMARK Breast Biopsy Site Marker
• 10841911102141: HydroMARK Breast Biopsy Site Marker
• 10841911102134: HydroMARK Breast Biopsy Site Marker
• 10841911102127: HydroMARK Breast Biopsy Site Marker
• 10841911102110: HydroMARK Breast Biopsy Site Marker
• 10841911102103: HydroMARK Breast Biopsy Site Marker
• 10841911102097: HydroMARK Breast Biopsy Site Marker
• 10841911102080: HydroMARK Breast Biopsy Site Marker
• 20841911100021: HydroMARK Breast Biopsy Site Marker
• 10841911102066: HydroMARK Breast Biopsy Site Marker
• 10841911102059: HydroMARK Breast Biopsy Site Marker