Cerafix® Dura Substitute

FDA UDI

Class II (US FDA UDI)

by Acera Surgical Inc

Identity

Trade Name: Cerafix® Dura Substitute FDA UDI
Generic Name: Dura mater graft, synthetic FDA UDI
Device Name: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. FDA UDI
Model / Reference: C1-3X3 FDA UDI
Description: Cerafix® Dura Substitute is a resorbable implant for repair of dural defects and is to be used with tensionless sutures. Cerafix® Dura Substitute is a soft, white, pliable, nonfriable, porous polymer matrix. FDA UDI

Identifiers

Primary DI / UDI-DI: 00854258006037 FDA UDI
FDA Product Code: GXQ FDA UDI
GMDN Term: Dura mater graft, synthetic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5910 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 7.5 Centimeter FDA UDI
Length — 7.5 Centimeter FDA UDI
Width — 3 Inch FDA UDI
Length — 3 Inch FDA UDI

Category: Dura mater graft, synthetic

Cerafix® Dura Substitute by Acera Surgical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Acera Surgical Inc

Sources (1)

FDA UDI c46bf6d1-aeac-40e1-ad1a-1d3b92a99597 35 fields · synced Jun 6, 2026