BMAC Diamond Needle Assembly

GUDID 00810131880989

SURGENTEC, LLC

Bone marrow biopsy procedure kit

• Primary Device ID: 00810131880989
• NIH Device Record Key: c48ba1a0-f183-412e-bed2-585ea21e4eb8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BMAC Diamond Needle Assembly
• Version Model Number: SR07-1200
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	00810131880989 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240664

FDA Product Code

• PDQ: Neurosurgical Nerve Locator

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: 2025-01-08
• Device Publish Date: 2024-12-31

Devices Manufactured by SURGENTEC, LLC

• 00810131880934 - BMAN Solid Diamond Needle Pouched: 2025-01-08
• 00810131880941 - BMAN Solid Diamond Needle: 2025-01-08
• 00810131880958 - BMAN Solid Diamond Needle Kit: 2025-01-08
• 00810131880965 - BMAN Solid Diamond Needle - Two Pack: 2025-01-08
• 00810131880972 - BMAN Solid Diamond Needle Kit - Two Pack: 2025-01-08
• 00810131880989 - BMAC Diamond Needle Assembly: 2025-01-08
• 00810131880989 - BMAC Diamond Needle Assembly: 2025-01-08
• 00810131880996 - BMAC Diamond Needle Pouched: 2025-01-08
• 00810131881009 - BMAC Diamond Needle: 2025-01-08