HydroMARK Breast Biopsy Site Marker

GUDID 10841911102189

HydroMARK Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Imaging lesion localization marker, implantable

• Primary Device ID: 10841911102189
• NIH Device Record Key: 395d4301-cb4d-4f3a-87b7-6346aa575823
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroMARK Breast Biopsy Site Marker
• Version Model Number: 4010-03-09-T1
• 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: true
• 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
• 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
• 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	00841911102182 [Primary]
GS1	10841911102189 [Package]; Contains: 00841911102182; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161021

FDA Product Code

• NEU: Marker, Radiographic, Implantable

Sterilization

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

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

Ethylene Oxide

[10841911102189]

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