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ClearFit

FDA UDI

Class I (US FDA UDI)

by Longeviti Neuro Solutions

Identity

Trade Name
ClearFit FDA UDI
Generic Name
Cranial resinous compound FDA UDI
Device Name
ClearFit 1.4cm Cover with Slot FDA UDI
Model / Reference
171738 FDA UDI
Description
ClearFit 1.4cm Cover with Slot FDA UDI

Identifiers

Primary DI / UDI-DI
00855113008722 FDA UDI
510(k) Number
K231920 FDA UDI
FDA Product Code
GNX FDA UDI
GMDN Term
Cranial resinous compound FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3330 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

Yes

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Cranial resinous compound

ClearFit by Longeviti Neuro Solutions — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial resinous compound.

Cleared under the same submission

K231920 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Longeviti Neuro Solutions

Sources (1)

  • FDA UDI 8682c298-fadc-4c42-8388-308b3c9c195f 34 fields · synced May 30, 2026