HydroMARK Plus CA000893002

GUDID 00841911103110

HydroMARK Plus Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Radiological image marker, implantable

• Primary Device ID: 00841911103110
• NIH Device Record Key: da31c44f-3661-48cc-b7d6-8f2a35df60ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HydroMARK Plus
• Version Model Number: 4010-MR-15-T6
• Catalog Number: CA000893002
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841911103110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221961

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: 2026-03-13
• Device Publish Date: 2026-03-05

On-Brand Devices [HydroMARK Plus]

• 00841911102878: 4010-02-15-T5
• 00841911102922: Breast biopsy site marker
• 00841911103110: HydroMARK Plus Breast Biopsy Site Marker
• 10841911102936: HydroMARK Plus Breast Biopsy Site Marker