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Actifuse ABX

FDA UDI

Class II (US FDA UDI)

by Apatech Ltd

Identity

Trade Name
Actifuse ABX FDA UDI
Generic Name
Bone matrix implant, synthetic, non-antimicrobial FDA UDI
Device Name
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size FDA UDI
Model / Reference
506005078060 FDA UDI
Description
Bone Graft Substitute - Silicate Substituted Calcium Phosphate - 1.5ml pack size FDA UDI

Identifiers

Catalog Number
506005078060 FDA UDI
Primary DI / UDI-DI
05060050780609 FDA UDI
FDA Product Code
MQV FDA UDI
LYC FDA UDI
GMDN Term
Bone matrix implant, synthetic, non-antimicrobial 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Total Volume — 1.5 Milliliter FDA UDI

Category: Bone matrix implant, synthetic, non-antimicrobial

Actifuse ABX by Apatech Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone matrix implant, synthetic, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Apatech Ltd

Sources (1)

  • FDA UDI 3318a640-0889-453b-ac0e-c2249ceb95c3 37 fields · synced Jun 1, 2026