BioSphere MIS Kit

GUDID M958BMS250KT0

SYNERGY BIOMEDICAL, LLC

Bone matrix implant, synthetic, non-antimicrobial

• Primary Device ID: M958BMS250KT0
• NIH Device Record Key: 7983ebd0-d040-44c6-8161-e2ab41d101ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioSphere MIS Kit
• Version Model Number: BMS-250KT
• Company DUNS: 078270195
• Company Name: SYNERGY BIOMEDICAL, 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: false
• 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

Customer Support Contacts

• Phone: 484-902-8141
• Email: info@synergybiomedical.com
• Phone: 484-902-8141
• Email: info@synergybiomedical.com
• Phone: 484-902-8141
• Email: info@synergybiomedical.com
• Phone: 484-902-8141
• Email: info@synergybiomedical.com
• Phone: 484-902-8141
• Email: info@synergybiomedical.com

Device Dimensions

• Total Volume: 5.5 Milliliter
• Total Volume: 5.5 Milliliter
• Total Volume: 5.5 Milliliter
• Total Volume: 5.5 Milliliter
• Total Volume: 5.5 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M958BMS250KT0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173301

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2024-12-17
• Device Publish Date: 2024-12-09

Devices Manufactured by SYNERGY BIOMEDICAL, LLC

• M958BMS250KT0 - BioSphere MIS Kit: 2024-12-17
• M958BMS250KT0 - BioSphere MIS Kit: 2024-12-17
• M958BMS250RC0 - BioSphere MIS Replacement Cannula: 2024-12-17
• M958BSF000300 - BioSphere Flex SP Extremities, Small: 2021-06-09 BioSphere Flex SP Extremities, Small
• M958BSF000400 - BioSphere Flex SP Extremities, Medium: 2021-06-09 BioSphere Flex SP Extremities, Medium
• M958BSF250500 - BioSphere Flex, Medium: 2021-06-09 BioSphere Flex, Medium
• M958BSF251000 - BioSphere Flex, Large: 2021-06-09 BioSphere Flex, Large
• M958BSF00075 - BioSphere Flex SP: 2020-02-10