LumiMARK Breast Biopsy Site Marker

GUDID 00841911103004

Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

Radiological image marker, implantable

• Primary Device ID: 00841911103004
• NIH Device Record Key: b6ef20ca-8189-4a23-9804-273bd1af1483
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumiMARK Breast Biopsy Site Marker
• Version Model Number: LM0215R
• 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	00841911103004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232615

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: 2024-03-19
• Device Publish Date: 2024-03-11

On-Brand Devices [LumiMARK Breast Biopsy Site Marker]

• 10841911103001: LM0215R
• 10841911102998: Breast Biopsy Site Marker
• 10841911102981: Breast Biopsy Site Marker
• 00841911103004: Breast Biopsy Site Marker
• 00841911102991: LumiMARK Breast Biopsy Site Marker
• 00841911102984: Breast Biopsy Site Marker