SurFuse

GUDID 08809204339013

Hans Biomed Corp.

Bone matrix implant, human-derived

• Primary Device ID: 08809204339013
• NIH Device Record Key: 72fe60b0-7b10-4ed0-a1f8-a9efa57afbeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurFuse
• Version Model Number: SG03
• Company DUNS: 689512625
• Company Name: Hans Biomed Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809204339013 [Primary]

FDA Product Code

• MBP: Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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: 2020-07-17
• Device Publish Date: 2015-09-24

On-Brand Devices [SurFuse]

• 08809204339143: SP10
• 08809204339136: SP8
• 08809204339129: SP5
• 08809204339112: SP3
• 08809204339105: SP1
• 08809204339099: SP05
• 08809204339082: SP03
• 08809204339075: SG10
• 08809204339068: SG8
• 08809204339051: SG5
• 08809204339044: SG3
• 08809204339037: SG1
• 08809204339020: SG05
• 08809204339013: SG03