LumiMARK Breast Biopsy Site Marker

GUDID 10841911102981

Breast Biopsy Site Marker

DEVICOR MEDICAL PRODUCTS, INC.

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 Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable Radiological image marker, implantable

• Primary Device ID: 10841911102981
• NIH Device Record Key: b8ffa0c9-5b7b-4b3e-a5d5-93b1ee2af023
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LumiMARK Breast Biopsy Site Marker
• Version Model Number: LM0215T
• 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	10841911102981 [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