IntraSpin BFUSE110

GUDID D742BFUSE1101

IntraSpin Fuse, IS110

INTRA-LOCK INTERNATIONAL, INC.

Haematological concentrate system

• Primary Device ID: D742BFUSE1101
• NIH Device Record Key: 81b0fb3a-6a65-4014-80b4-fe1625e78a3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IntraSpin
• Version Model Number: BFUSE110
• Catalog Number: BFUSE110
• Company DUNS: 131500998
• Company Name: INTRA-LOCK INTERNATIONAL, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-330-0338
• Email: info@intra-lock.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D742BFUSE1101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK120048

FDA Product Code

• ORG: Platelet And Plasma Separator For Bone Graft Handling

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-30
• Device Publish Date: 2019-10-22

On-Brand Devices [IntraSpin]

• D742BTUBEHOLD1: IntraSpin Tube Holder Replacement
• D742BROTOR1: IntraSpin Rotor, 110v & 220v
• D742BPOWER2201: IntraSpin Power Cord, 220v
• D742BPOWER1101: IntraSpin Power Cord, 110v
• D742BHEX1: IntraSpin Hex Key, 110v & 220v
• D742BFUSE2201: IntraSpin Fuse, IS220
• D742BFUSE1101: IntraSpin Fuse, IS110