MICROFUSE

GUDID 00849044044157

MicroFuse ST MIS w/ BaSO4/CaSO4, 6.5 x 75mm, Lordotic

GLOBUS MEDICAL, INC.

Synthetic bone graft

• Primary Device ID: 00849044044157
• NIH Device Record Key: 2470327a-1d90-41ff-8a43-3a91a662d68b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MICROFUSE
• Version Model Number: 838.063S
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter
• Length: 75 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044044157 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102392

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-11-08

On-Brand Devices [MICROFUSE]

• 00849044044263: MicroFuse Putty, 10cc
• 00849044044256: MicroFuse Putty, 5cc
• 00849044044249: MicroFuse Putty, 2.5cc
• 00849044044232: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 12mm
• 00849044044225: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 11mm
• 00849044044218: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 10mm
• 00849044044201: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 9mm
• 00849044044195: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 8mm
• 00849044044188: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 7mm
• 00849044044171: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 6mm
• 00849044044164: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 14mm x 12mm x 5mm
• 00849044044157: MicroFuse ST MIS w/ BaSO4/CaSO4, 6.5 x 75mm, Lordotic
• 00849044044140: MicroFuse ST MIS w/ BaSO4/CaSO4, 6.5 x 55mm, Lordotic
• 00849044044133: MicroFuse ST MIS w/ BaSO4/CaSO4, 6.5 x 75mm
• 00849044044126: MicroFuse ST MIS w/ BaSO4/CaSO4, 6.5 x 55mm
• 00849044043952: MicroFuse St Granules, 20cc, Assembly
• 00849044043945: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 12mm
• 00849044043938: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 11mm
• 00849044043921: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 10mm
• 00849044043914: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 9mm
• 00849044043907: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 8mm
• 00849044043891: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 7mm
• 00849044043884: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 6mm
• 00849044043877: MicroFuse LT Slotted Block, w/BaSO4/CaSO4, 7deg, 14mm x 12mm x 5mm
• 00849044043860: MicroFuse ST Granules, 10cc
• 00849044043853: MicroFuse ST Granules, 5cc
• 00849044043846: MicroFuse ST Granules, 2.5cc, Assembly