SurFuse

FDA UDI

Class II (US FDA UDI)

by Hans Biomed Corporation

Identity

Trade Name: SurFuse FDA UDI
Generic Name: Bone matrix implant, human-derived FDA UDI
Model / Reference: SP3 FDA UDI

Identifiers

Primary DI / UDI-DI: 08809204339112 FDA UDI
FDA Product Code: MBP FDA UDI
MQV FDA UDI
NUN FDA UDI
GMDN Term: Bone matrix implant, human-derived FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3045 FDA UDI
872.3930 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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Single Use

Yes

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Implantable

Yes

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Contains Latex

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Prescription Use

Yes

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Over-the-Counter

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Convenience Kit

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Combination Product

FDA UDI

HCT/P

Yes

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Premarket Exempt

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Lot / Batch Number

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Serial Number

Yes

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Expiration Date

Yes

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Manufacturing Date

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Category: Bone matrix implant, human-derived

Hans Biomed Corp.'s SurFuse bone matrix implant is a bioabsorbable, osteoconductive device designed to fill bony voids or gaps caused by trauma or surgery. Made from human-derived demineralized bone matrix (DBM), it stimulates new bone growth and has demonstrated at least potential osteoinductivity.

Similar devices

Also classified as Bone matrix implant, human-derived.

DBM Putty 10.0cc Jar — Xtant Medical Holdings, Inc. · Class II
DBM Putty 10.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
OsteoSelect (DBM) Putty 5.0cc in a Syringe — Xtant Medical Holdings, Inc. · Class II
InterGro DBM Paste — Biomet Orthopedics, Inc. · Class II
GRAFTON®and GRAFTON PLUS®Demineralized Bone Matrix (DBM) — MEDTRONIC SOFAMOR DANEK, INC. · Class II
Trel-X Putty — Integra Lifesciences Corp. · Class II
Puros® — ZIMMER SPINE, INC. · Class II
BioSet® — Rti Surgical, Inc. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Hans Biomed Corporation

Sources (1)

FDA UDI 3afc22fe-e1ee-4bc8-9ed0-acb0de738d28 32 fields · synced Jul 28, 2026