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ClearFit

FDA UDI

Class II (US FDA UDI)

by Longeviti Neuro Solutions

Identity

Trade Name
ClearFit FDA UDI
Generic Name
Cranial resinous compound FDA UDI
Device Name
ClearFit OTS 2.4cm Cover FDA UDI
Model / Reference
171735 FDA UDI
Description
ClearFit OTS 2.4cm Cover FDA UDI

Identifiers

Primary DI / UDI-DI
00855113008494 FDA UDI
510(k) Number
K212058 FDA UDI
K231920 FDA UDI
FDA Product Code
GXN FDA UDI
PJN FDA UDI
GMDN Term
Cranial resinous compound 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

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

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 II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranial resinous compound.

Cleared under the same submission

K212058 also covers:

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 6258de2c-1530-4631-84f3-80003a08379c 34 fields · synced Jun 6, 2026