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CranioFit

FDA UDI

Class II (US FDA UDI)

by Bioplate, Inc.

Identity

Trade Name
CranioFit FDA UDI
Generic Name
Cranioplasty plate, non-alterable FDA UDI
Device Name
CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) FDA UDI
Model / Reference
KT-T6L10H2 FDA UDI
Description
CranioFit PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) FDA UDI

Identifiers

Catalog Number
CF26060011 FDA UDI
Primary DI / UDI-DI
M384CF260600110 FDA UDI
FDA Product Code
GXN FDA UDI
GMDN Term
Cranioplasty plate, non-alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Cranioplasty plate, non-alterable

CranioFit by Bioplate, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, non-alterable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bioplate, Inc.

Sources (1)

  • FDA UDI 5cc26fca-a21c-4a8c-92fb-77019851e87d 35 fields · synced May 31, 2026